Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1961 participants
INTERVENTIONAL
2007-05-29
2020-03-30
Brief Summary
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Detailed Description
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Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A gene, which may predict for benefit from anthracycline-based chemotherapy.
We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients, it would not only be an important advance in the understanding of the biology of cancer, but it would also be of significant clinical benefit to women with breast cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TC
docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2
Docetaxel
Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
Cyclophosphamide
600 mg/m2 IV over 15-30 minutes on Day 1.
TAC
doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2
Docetaxel
Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
Doxorubicin
• 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).
Cyclophosphamide
600 mg/m2 IV over 15-30 minutes on Day 1.
Interventions
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Docetaxel
Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
Doxorubicin
• 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).
Cyclophosphamide
600 mg/m2 IV over 15-30 minutes on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Has had baseline bilateral mammography
* It has been \<84 days since the date of definitive surgery (eg, mastectomy or, in the case of a breast-sparing procedure, axillary dissection) with adequate wound healing, as determined by the Treating Physician
* Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential \[not surgically sterilized and between menarche and 1 year postmenopause\])
* If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
* Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VI).
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form
Exclusion 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.
* Is pregnant or breastfeeding
* Is deemed unable to comply with requirements of study
18 Years
70 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne L Blum, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern AZ Hematology Oncology Associates-AOA
Sedona, Arizona, United States
Arizona Oncology Associates DBA HOPE
Tucson, Arizona, United States
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St. Jude Hertiage Medical Group
Fullerton, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Antelope Valley Cancer Center
Lancaster, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
University of California-Los Angeles
Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, United States
Ventura County Hematology-Oncology Specialist
Oxnard, California, United States
SAMSUM Clinic
Santa Barbara, California, United States
Santa Barabra Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States
Flordia Cancer Specialist
Fort Myers, Florida, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
Advanced Medical Specialist
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
Hematology Oncology Associates of IL
Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Hope Center
Terre Haute, Indiana, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Alliance Hematology Oncology PA
Westminster, Maryland, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Arch Medical Services, Inc.
St Louis, Missouri, United States
Comprehensive Cancer Center of Nevada
Henderson, Nevada, United States
Hematology-Oncology Associates of NNJ, P.A.
Morristown, New Jersey, United States
Southern New Mexico Cancer Center
Las Cruces, New Mexico, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Interlakes Oncology Hematology, PC
Rochester, New York, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Mahoning Valley Hematology Oncology Associates
Boardman, Ohio, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Chattanooga Oncology & Hematology Associates, PC
Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Cancer Center-Abilene (South)
Abilene, Texas, United States
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States
Texas Cancer Center
Arlington, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology -Bedford
Bedford, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Texas Oncology
Garland, Texas, United States
Texas Oncology, P.A.
Houston, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
South Texas Cancer Center-McAllen
McAllen, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Texas Oncology-Odessa
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, United States
HOAST-Medical Dr.
San Antonio, Texas, United States
Texas Cancer Center-Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care and Research
Waco, Texas, United States
Texas Oncology PA
Webster, Texas, United States
Texoma Cancer Center
Wichita Falls, Texas, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Onc and Hem Associates os SW VA, Inc.
Salem, Virginia, United States
Highline Medical Oncology
Burien, Washington, United States
Pudget Sound Cancer Center-Edmonds
Edmonds, Washington, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States
Cancer Care Northwest-South
Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Raleigh Regional Cancer Center
Beckley, West Virginia, United States
Countries
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References
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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.
Other Identifiers
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11271
Identifier Type: OTHER
Identifier Source: secondary_id
06090
Identifier Type: -
Identifier Source: org_study_id
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