Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
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| ClinicalTrials.gov Identifier: NCT00004125 |
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Recruitment Status :
Completed
First Posted : August 25, 2003
Last Update Posted : January 29, 2010
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
- 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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer |
| Study Start Date : | October 1999 |
| Actual Primary Completion Date : | May 2007 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
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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
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Hormone receptor status:
- Estrogen receptor status positive, negative, or unknown
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No history of myocardial infarction
- No congestive heart failure
- No significant ischemic or valvular heart disease
Other:
- 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:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for breast cancer
Endocrine therapy:
- 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
Radiotherapy:
- No prior radiotherapy for this malignancy
- At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ
Surgery:
- See Disease Characteristics
- Less than 84 days since prior surgical procedure to adequately treat primary tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004125
Show 48 study locations
| Study Chair: | Joseph A. Sparano, MD | Albert Einstein College of Medicine | |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic | |
| Study Chair: | Silvana Martino, DO | Saint John's Cancer Institute | |
| Study Chair: | Vicky E. Jones, MD | University of California, San Diego |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00004125 |
| Other Study ID Numbers: |
CDR0000067353 E1199 CLB-49906 NCCTG-E1199 SWOG-E1199 |
| First Posted: | August 25, 2003 Key Record Dates |
| Last Update Posted: | January 29, 2010 |
| Last Verified: | January 2010 |
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stage II breast cancer stage IIIA breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Paclitaxel Docetaxel Cyclophosphamide Doxorubicin Liposomal doxorubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Estrogen Antagonists Hormone Antagonists |