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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00093795 |
Purpose
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 Drug: Gemcitabine Drug: Paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
| Enrollment: | 4894 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
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 cycles.
|
Drug: Cyclophosphamide
500 mg/m2 IV every 21 days for 6 cycles
Drug: Docetaxel
75 mg/m2 IV every 21 days for 6 cycles
Other Name: Taxotere
Drug: Doxorubicin
50 mg/m2 IV every 21 days for 6 cycles
|
|
Active Comparator: Arm II
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 cycles. 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 cycles.
|
Drug: Paclitaxel
14 days after the last dose of AC 175 mg/m2 IV every 14 days for 4 cycles
Other Name: Taxol
Drug: Cyclophosphamide
600 mg/m2 IV every 14 days for 4 cycles
Drug: Doxorubicin
60 mg/m2 IV every 14 days for 4 cycles
|
|
Experimental: Arm III
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 cycles.
|
Drug: Gemcitabine
14 days after the last dose of AC 2000 mg/m2 IV every 14 days for 4 cycles
Other Name: Gemzar
Drug: Paclitaxel
14 days after the last dose of AC 175 mg/m2 IV every 14 days for 4 cycles
Other Name: Taxol
Drug: Cyclophosphamide
600 mg/m2 IV every 14 days for 4 cycles
Drug: Doxorubicin
60 mg/m2 IV every 14 days for 4 cycles
|
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 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 dose 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.
Eligibility| 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
Contacts and Locations| 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 | |
| Study Chair: | Sandra M. Swain, MD | Washington Hospital Center |
More Information
| Responsible Party: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00093795 History of Changes |
| Obsolete Identifiers: | NCT00191958 |
| Other Study ID Numbers: | NSABP B-38, U10CA012027 |
| Study First Received: | October 6, 2004 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Ethics Review Committee; Canada: Health Canada; Ireland: Irish Medicines Board; Ireland: Research Ethics Committee |
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stage II breast cancer stage IIIA breast cancer stage IIIC breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Gemcitabine Docetaxel Doxorubicin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents |