|Phase III||Treatment||Completed||18 and over||NCI, Other||CDR0000067353|
E1199, CLB-49906, NCCTG-E1199, SWOG-E1199, NCT00004125
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
Further Study Information
- Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide.
- Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population.
- Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients.
- Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast conservation surgery). Patients are randomized to one of four treatment arms.
- Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses.
- Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.
- Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.
- Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.
Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen daily for 5 years.
After completion of all chemotherapy, patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigator's discretion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27 years.
- Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0)
- Primary tumor at least 2.1 cm in diameter for node-negative disease
- Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above
- Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR
- Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)
- Additional axillary nodes may be obtained provided they are also negative for metastasis
- Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy
- Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed)
- Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed
- Hormone receptor status:
- Estrogen receptor status positive, negative, or unknown
- 18 and over
- Not specified
- Not specified
- Not specified
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- No history of myocardial infarction
- No congestive heart failure
- No significant ischemic or valvular heart disease
- No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- No prior chemotherapy for breast cancer
- Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
- Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed
- No concurrent tamoxifen or other SERMs
- No prior radiotherapy for this malignancy
- At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ
- See Disease Characteristics
- Less than 84 days since prior surgical procedure to adequately treat primary tumor
Trial Lead Organizations/Sponsors
Eastern Cooperative Oncology GroupNational Cancer Institute
North Central Cancer Treatment Group
Southwest Oncology Group
Cancer and Leukemia Group B
|Joseph A. Sparano||Study Chair|
|Edith A. Perez||Study Chair|
|Silvana Martino||Study Chair|
|Vicky E. Jones, MD||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004125
Information obtained from ClinicalTrials.gov on November 20, 2012
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