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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093795 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Gemcitabine hydrochloride Gemcitabine Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed By DD Paclitaxel (DD AC→P); DD AC Followed By DD Paclitaxel Plus Gemcitabine (DD AC→PG) |
Estimated Enrollment: | 4800 |
Study Start Date: | October 2004 |
Arms | Assigned Interventions |
Arm I: Active Comparator
Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30 minutes, and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses.
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Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
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Arm II: Active Comparator
Patients receive AC chemotherapy comprising doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 14 days for 4 courses. Beginning 14 days after the last dose of AC, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses.
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Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
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Arm III: Experimental
Patients receive AC chemotherapy as in arm II. Beginning 14 days after the last dose of AC, patients receive paclitaxel as in arm II and gemcitabine IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 4 courses.
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Drug: doxorubicin hydrochloride
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: paclitaxel
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive lymph nodes (1-3 vs 4-9 vs ≥ 10), hormone receptor status (estrogen receptor [ER]- and progesterone receptor [PgR]- negative vs ER- and/or PgR-positive), type of prior surgery and planned radiotherapy (lumpectomy and local radiotherapy [RT] without regional RT vs lumpectomy and local RT with regional RT vs mastectomy without RT vs mastectomy with local and/or regional RT). Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Beginning 3-12 weeks after the last dose of chemotherapy, patients with ER-positive and/or PgR-positive tumors receive hormonal therapy.
Beginning no sooner than 3 weeks after the last course of chemotherapy, patients treated with lumpectomy undergo whole-breast radiotherapy. Patients treated with mastectomy may undergo chest wall and/or regional nodal radiotherapy.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,800 patients will be accrued for this study within 4 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer, meeting all of the following staging criteria:
Ipsilateral lymph nodes pN1 (pN1mi, pN1a, pN1b, or pN1c), pN2a, pN3a, or pN3b* by pathologic evaluation
Must have completed 1 of the following procedures for evaluation of pathological nodal status:
Sentinel lymphadenectomy alone allowed provided 1 of the following criteria is met:
Must have undergone prior lumpectomy or total mastectomy
Lumpectomy patients:
Surgical margins must be histologically free of invasive tumor AND ductal carcinoma in situ (DCIS) (lobular carcinoma in situ [LCIS] allowed)
No prior breast cancer, including DCIS
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No cardiac disease that would preclude the use of anthracyclines, including any of the following:
Other
No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, melanoma in situ, or carcinoma in situ of the colon
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormone replacement therapy, or Femring®)
Radiotherapy
Surgery
Other
United States, Alabama | |||||
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, Alaska | |||||
Providence Cancer Center | |||||
Anchorage, Alaska, United States, 99508 | |||||
United States, Florida | |||||
Robert and Carol Weissman Cancer Center at Martin Memorial | |||||
Stuart, Florida, United States, 34994 | |||||
United States, Kentucky | |||||
Lucille P. Markey Cancer Center at University of Kentucky | |||||
Lexington, Kentucky, United States, 40536-0093 | |||||
United States, Massachusetts | |||||
South Shore Hospital | |||||
South Weymouth, Massachusetts, United States, 02190 | |||||
United States, Nebraska | |||||
Methodist Estabrook Cancer Center | |||||
Omaha, Nebraska, United States, 68114 | |||||
United States, New Jersey | |||||
CCOP - Northern New Jersey | |||||
Hackensack, New Jersey, United States, 07601 | |||||
United States, North Carolina | |||||
Blumenthal Cancer Center at Carolinas Medical Center | |||||
Charlotte, North Carolina, United States, 28232-2861 | |||||
United States, North Dakota | |||||
Altru Cancer Center at Altru Hospital | |||||
Grand Forks, North Dakota, United States, 58201 | |||||
United States, Ohio | |||||
Community Oncology Group at Cleveland Clinic Cancer Center | |||||
Independence, Ohio, United States, 44131 | |||||
United States, Pennsylvania | |||||
Chestnut Hill Healthcare Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19118 | |||||
United States, Washington | |||||
Madigan Army Medical Center - Tacoma | |||||
Tacoma, Washington, United States, 98431 |
National Surgical Adjuvant Breast and Bowel Project (NSABP) |
National Cancer Institute (NCI) |
Study Chair: | Sandra M. Swain, MD | Washington Hospital Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000390286, NSABP-B-38 |
First Received: | October 6, 2004 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00093795 |
Health Authority: | United States: Federal Government |
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