Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer
6 other identifiers
interventional
46
1 country
230
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started May 2010
Typical duration for phase_2 breast-cancer
230 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, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2014
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedMay 8, 2018
April 1, 2018
1.7 years
March 12, 2010
December 12, 2016
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Confirmed Tumor Responses (Complete or Partial Response)
The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to \<1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.
Up to 5 years
Secondary Outcomes (5)
Time to Disease Progression
Up to 5 years
6-month Progression-free Survival Rate
At 6 months
Overall Survival Time
Up to 5 years
Duration of Response
Up to 5 years
Toxicity
Up to 1 year after treatment
Study Arms (2)
Arm I
EXPERIMENTALPatients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II
EXPERIMENTALPatients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Women or men
- ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast and clinical evidence of metastatic breast cancer.
- Pre-treatment requirements:
- Must have been previously treated in neoadjuvant, adjuvant or metastatic setting with anthracycline and/or taxane.
- Must have received 2-3 prior chemotherapy treatment regimens NOTE: If NO prior (neo)adjuvant chemotherapy, patient must have received a minimum of 2 prior chemotherapy regimens in the metastatic setting.
- NOTE: If prior (neo)adjuvant chemotherapy HAS been given, patient must have received at least 1 prior chemotherapy regimen in the metastatic setting.
- Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting.
- Unlimited prior hormonal therapy is allowed.
- Patients must have measurable disease as defined in the protocol.
- Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
- The following laboratory values obtained ≤15 days prior to registration.
- Hemoglobin ≥10.0g/dL
- ANC ≥1500/mm\^3
- Platelet count ≥100,000/mL
- +9 more criteria
You may not qualify if:
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
- Stage III or IV invasive cancer (other than breast cancer) in ≤3 years prior to registration (with the exception of non-melanoma skin cancer).
- HER2 positive breast cancer (3+ by IHC or FISH amplified) breast cancer by ASCO/CAP guidelines
- Has already received lifetime cumulative treatment with doxorubicin equivalent to \>400 mg/m2.
- \>3 prior chemotherapy regimens for breast cancer.
- NOTE: This number includes (neo)adjuvant chemotherapy, if given. If (neo)adjuvant chemotherapy HAS been given it counts as one (1) regimen.
- Major surgery, chemotherapy, or immunologic therapy ≤3 weeks prior to registration.
- NOTE: If patient has received prior treatment with bevacizumab, treatment on this trial should not begin until ≥4 weeks after the last dose of bevacizumab.
- Radiotherapy ≤4 weeks prior to registration, except if to a non-target lesion only.
- Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting.
- Acute adverse events from radiation must have resolved to ≤Grade 1 (according to current version of NCI CTCAE).
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (230)
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu, Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pacific Cancer Institute - Maui
Wailuku, Hawaii, 96793, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center - West Lakes
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, 52501, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Michiana Hematology Oncology PC - Niles
Niles, Michigan, 49120, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Comprehensive Cancer Care, PC
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
Hematology Oncology Associates, PC
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, 88011, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Broadway
Fargo, North Dakota, 58122, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
North Coast Cancer Care - Clyde
Clyde, Ohio, 43410, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
CCOP - Dayton
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Willamette Falls Hospital
Oregon City, Oregon, 97045, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, 18840, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, 25701, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Sideras K, Hillman DW, Giridhar K, Ginos BF, Tenglin RC, Liu H, Chen B, Tan W, Gross GG, Mowat RB, Dueck AC, Perez EA, Moreno-Aspitia A. Randomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance). Oncologist. 2022 Apr 21;27(5):338-e368. doi: 10.1093/oncolo/oyab065. Online ahead of print.
PMID: 35445723DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alvaro Moreno-Asptia, M.D.
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Alvaro Moreno-Asptia, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
November 15, 2014
Last Updated
May 8, 2018
Results First Posted
February 23, 2017
Record last verified: 2018-04