Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
7 other identifiers
interventional
454
1 country
448
Brief Summary
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Longer than P75 for phase_2
448 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
July 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedResults Posted
Study results publicly available
March 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2025
CompletedSeptember 30, 2025
September 1, 2025
5 years
March 12, 2009
January 12, 2015
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
At the time of definitive surgical removal, up to 28 weeks
Secondary Outcomes (9)
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
At the time of definitive surgical removal, up to 28 weeks
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
at definitive surgery, up to 28 weeks
Radiographic Response Assessed by Tumor Measurement
Baseline; at completion of neoadjuvant therapy
Clinical Response Assessed by Tumor Measurement
Baseline; at completion of neoadjuvant therapy
- +4 more secondary outcomes
Study Arms (4)
Arm I (paclitaxel, doxorubicin, cyclophosphamide)
ACTIVE COMPARATORPatients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
Arm II (paclitaxel, ddAC, bevacizumab)
EXPERIMENTALPatients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
Arm III (paclitaxel, ddAC, carboplatin)
EXPERIMENTALPatients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)
EXPERIMENTALPatients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.
Interventions
Given IV
Given IV
Given IV
Given IV
Correlative studies
Given IV
Eligibility Criteria
You may qualify if:
- Invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional biopsy not permitted)
- The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) negative or staining present in =\< 10% of invasive cancer cells by immunohistochemistry (IHC)
- The invasive tumor must be HER2-negative, defined as IHC 0-1+ or with a fluorescent in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) of \< 2.0 if IHC 2+
- Clinical stage II-III invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy; patients with inflammatory breast cancer are not eligible; staging to rule out metastatic disease is recommended for clinical stage III patients
- Patients with multicentric or bilateral disease are eligible if the target lesion meets eligibility criteria
- Patient agrees to undergo pretreatment research biopsies
- No prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent for this cancer
- The target lesion in the breast must be \>= 1 cm, clinically or radiographically; palpable or radiographically measurable axillary adenopathy will be recorded but will not serve as measurable disease for the primary endpoint; patients with axillary disease only (no identifiable tumor in the breast that is \>= 1 cm on physical exam or radiographic study) are not eligible to participate
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower gastrointestinal \[GI\] bleeding) within 6 months of registration are not eligible
- No serious or non-healing wound, skin ulcers or bone fracture; no abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; no major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study
- The following are not considered to be major surgical procedures that would be prohibited in the 28 days prior to, or following study randomization: obtaining the required research needle biopsies; placement of a radiopaque clip to localize a tumor or tumors for subsequent surgical resection; placement of a port for central venous access; fine needle aspiration of a prominent or suspicious axillary lymph node; needle biopsy of a clinically or radiographically detected lesion to rule out metastatic disease; or pretreatment sentinel lymph node sampling
- No baseline neuropathy grade \>= 2
- Zubrod performance status 0-1
- Pregnant or nursing women are not eligible; all women of reproductive potential must have a negative pregnancy test at baseline and agree to use an effective, non-hormonal method of contraception during the entire period of treatment on the study
- Patients with congestive heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure \[SBP\] \> 160 or diastolic blood pressure \[DBP\] \> 90), uncontrolled or symptomatic arrhythmia, or grade II or greater peripheral vascular disease
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (448)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Sutter Cancer Research Consortium
Novato, California, 94945, United States
Wilma Chan Highland Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
Salinas Valley Memorial
Salinas, California, 93901, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Breastlink Medical Group Inc
Santa Ana, California, 92705, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Banner McKee Medical Center
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Manchester Memorial Hospital
Manchester, Connecticut, 06040, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Cancer Center of South Florida-Lake Worth
Lake Worth, Florida, 33461, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Atlanta Regional CCOP
Atlanta, Georgia, 30342, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Emory Decatur Hospital
Decatur, Georgia, 30033, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pacific Cancer Institute of Maui
Wailuku, Hawaii, 96793, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Presence Resurrection Medical Center
Chicago, Illinois, 60631, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
West Suburban Medical Center
River Forest, Illinois, 60305, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
HaysMed
Hays, Kansas, 67601, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, 66204, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
New England Cancer Specialists
Westbrook, Maine, 04092, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
University Health Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Comprehensive Cancer Care PC
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Dartmouth Cancer Center - Manchester
Manchester, New Hampshire, 03102, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Coney Island Hospital
Brooklyn, New York, 11235, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Elmhurst Hospital Center
Elmhurst, New York, 11373, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Garnet Health Medical Center
Middletown, New York, 10940, United States
Mount Sinai Union Square
New York, New York, 10003, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
ECU Health Oncology Kinston
Kinston, North Carolina, 28501, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
UNC Rex Healthcare
Raleigh, North Carolina, 27607, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Nash UNC HealthCare
Rocky Mount, North Carolina, 27804, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Summa Health System - Barberton Campus
Barberton, Ohio, 44203, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, 73142, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Butler Memorial Hospital
Butler, Pennsylvania, 16001, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania, 17331, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Miriam Hospital
Providence, Rhode Island, 02906, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Roper Hospital
Charleston, South Carolina, 29401, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57117-5045, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Nashville Oncology Associates PC
Nashville, Tennessee, 37203, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Doctor's Hospital of Laredo
Laredo, Texas, 78041, United States
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, 79430, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Intermountain Health Care
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408, United States
Virginia Oncology Associates-Hampton
Hampton, Virginia, 23666, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
MultiCare Allenmore Hospital
Tacoma, Washington, 98405, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, 98405, United States
Saint Joseph Medical Center
Tacoma, Washington, 98405, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Saint Mary's Medical Center
Huntington, West Virginia, 25702, United States
Princeton Community Hospital
Princeton, West Virginia, 24740, United States
Fox Valley Surgical Associates Limited
Appleton, Wisconsin, 54911, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Cancer Care-Franklin
Franklin, Wisconsin, 53132, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Glendale
Glendale, Wisconsin, 53212, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (2)
Shepherd JH, Ballman K, Polley MC, Campbell JD, Fan C, Selitsky S, Fernandez-Martinez A, Parker JS, Hoadley KA, Hu Z, Li Y, Soloway MG, Spears PA, Singh B, Tolaney SM, Somlo G, Port ER, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon JR, Collyar D, Hahn OM, Hudis CA, Winer EP, Partridge A, Hyslop T, Carey LA, Perou CM, Sikov WM. CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer. J Clin Oncol. 2022 Apr 20;40(12):1323-1334. doi: 10.1200/JCO.21.01506. Epub 2022 Jan 19.
PMID: 35044810DERIVEDSikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
PMID: 25092775DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William M. Sikov, M.D.
- Organization
- Warren Alpert Medical School of Brown University, Department of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
William M Sikov
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
July 21, 2009
Primary Completion
August 1, 2014
Study Completion
September 2, 2025
Last Updated
September 30, 2025
Results First Posted
March 23, 2015
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.