TAC Versus TC for Adjuvant Breast Cancer
Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients
2 other identifiers
interventional
1,961
1 country
95
Brief Summary
The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started May 2007
Longer than P75 for phase_3 breast-cancer
95 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
Study Start
First participant enrolled
May 29, 2007
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedResults Posted
Study results publicly available
March 2, 2023
CompletedMarch 2, 2023
February 1, 2023
8 years
June 27, 2007
September 16, 2020
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients
The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among analyzed ITT patients. ITT patients are all patients who were randomized, whether or not they followed protocol. IDFS, defined as the time from the date of randomization to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free.
3 years from randomization into study
3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients
The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among per-protocol patients. Per-protocol only includes those patients who were randomized and received treatment as outlined in the protocol.
3 years from randomization into study
Secondary Outcomes (5)
3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients
3 years from randomization into study
3-year DFS-DCIS, OS and RFI Among Per-protocol Patients.
3 years from randomization into study
Number and Frequency of Participants by TOP2A Status by Study Treatment
10 years (from baseline to end of study participation)
3-year DFS Stratified by TOP2A Among TC Arm
3 years from randomization into study
3-year DFS Stratified by TOP2A Among TAC Arm
3 years from randomization into study
Study Arms (2)
TC
EXPERIMENTALdocetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2
TAC
ACTIVE COMPARATORdoxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2
Interventions
Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
• Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).
Eligibility Criteria
You may qualify if:
- Age \>18 to \<70 years old.
- Has known ER and PR status
- Has HER2 nonamplified disease, confirmed by FISH
- Has known menopausal status (see Section 7.3 for criteria)
- Meets 1 of the 3 following criteria:
- T1-3N1-3M0 if ER positive or negative
- T2-3N0M0 if ER positive or negative
- T1N0M0 if ER and PR negative
- Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)
- Has had no prior chemotherapy unless \>5 years ago
- Has an ECOG Performance Status (PS) 0-1
- Has laboratory values of: See protocol for specific details
- Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
- Has normal cardiac function as evidenced by a LVEF \>50%, but WNL by institutional standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same modality must be used consistently throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be WNL by institutional standard.
- Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease
- +7 more criteria
You may not qualify if:
- A woman will be excluded from this study if she meets any of the following criteria:
- Has any evidence of metastatic disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease
- Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes)
- Has Stage IV breast cancer (M1 disease on TNM staging system)
- Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Has had neoadjuvant chemotherapy for this breast cancer
- Has ever had a myocardial infarction (MI) or has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes
- Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone replacement therapy), or radiation therapy. Must discontinue prior to registering on the study.
- Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
- Has peripheral neuropathy \>Grade 1
- Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
- Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the diagnosis or assessment of any of the study drugs
- In an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Oncology Researchlead
- Sanoficollaborator
Study Sites (95)
Birmingham Hematology and Oncology
Birmingham, Alabama, 35205, United States
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Northern AZ Hematology Oncology Associates-AOA
Sedona, Arizona, 86336, United States
Arizona Oncology Associates DBA HOPE
Tucson, Arizona, 85704, United States
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
St. Jude Hertiage Medical Group
Fullerton, California, 92835, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
Antelope Valley Cancer Center
Lancaster, California, 93534, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
University of California-Los Angeles
Los Angeles, California, 90095, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325, United States
Ventura County Hematology-Oncology Specialist
Oxnard, California, 93030, United States
SAMSUM Clinic
Santa Barbara, California, 93105, United States
Santa Barabra Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
Rocky Mountain Cancer Center-Rose
Denver, Colorado, 80220, United States
Flordia Cancer Specialist
Fort Myers, Florida, 33916, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901, United States
Advanced Medical Specialist
Miami, Florida, 33176, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, 30045, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
Hematology Oncology Associates of IL
Chicago, Illinois, 60611, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46627, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, 66210, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Alliance Hematology Oncology PA
Westminster, Maryland, 21157, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 554404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Arch Medical Services, Inc.
St Louis, Missouri, 63141, United States
Comprehensive Cancer Center of Nevada
Henderson, Nevada, 89052, United States
Hematology-Oncology Associates of NNJ, P.A.
Morristown, New Jersey, 07960, United States
Southern New Mexico Cancer Center
Las Cruces, New Mexico, 88011, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Interlakes Oncology Hematology, PC
Rochester, New York, 14623, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
Mahoning Valley Hematology Oncology Associates
Boardman, Ohio, 44514, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, 19107, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Chattanooga Oncology & Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Cancer Center-Abilene (South)
Abilene, Texas, 79606, United States
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, 79106, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology -Bedford
Bedford, Texas, 76022, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230, United States
Texas Oncology
Dallas, Texas, 75231, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, 75237, United States
Texas Oncology
Dallas, Texas, 75246, United States
Texas Cancer Center
Denton, Texas, 76210, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, 79915, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Texas Oncology
Garland, Texas, 75042, United States
Texas Oncology, P.A.
Houston, Texas, 77024, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Longview Cancer Center
Longview, Texas, 75601, United States
South Texas Cancer Center-McAllen
McAllen, Texas, 78503, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology-Odessa
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460, United States
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, 78207, United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, 78217, United States
HOAST-Medical Dr.
San Antonio, Texas, 78229, United States
Texas Cancer Center-Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care and Research
Waco, Texas, 76712, United States
Texas Oncology PA
Webster, Texas, 77598, United States
Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Onc and Hem Associates os SW VA, Inc.
Salem, Virginia, 24153, United States
Highline Medical Oncology
Burien, Washington, 98166, United States
Pudget Sound Cancer Center-Edmonds
Edmonds, Washington, 98026, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, 99336, United States
Puget Sound Cancer Center-Seattle
Seattle, Washington, 98133, United States
Cancer Care Northwest-South
Spokane, Washington, 99202, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, 98684, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, 98902, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Raleigh Regional Cancer Center
Beckley, West Virginia, 25801, United States
Related Publications (1)
Geyer CE Jr, Blum JL, Yothers G, Asmar L, Flynn PJ, Robert NJ, Hopkins JO, O'Shaughnessy JA, Rastogi P, Puhalla SL, Hilton CJ, Dang CT, Gomez HL, Vukelja SJ, Lyss AP, Paul D, Brufsky AM, Colangelo LH, Swain SM, Mamounas EP, Wolmark N. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]). J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 Feb 9.
PMID: 38335467DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Taqi Mohammad
- Organization
- US Oncology Research
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne L Blum, MD
US Oncology Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
May 29, 2007
Primary Completion
May 31, 2015
Study Completion
March 30, 2020
Last Updated
March 2, 2023
Results First Posted
March 2, 2023
Record last verified: 2023-02