Combination Chemotherapy in Treating Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003519
First received: November 1, 1999
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Estimated Enrollment: 2778
Study Start Date: August 1998
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer. II. Compare the toxicity of DD to DC in this patient population.

OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient is less than 2 years from study entry; every 6 months if patient is 2-5 years from study entry; and every 12 months if patient is greater than 5 years from study entry.

PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed resectable adenocarcinoma of the breast Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease Tumor greater than 1.0 cm diameter May have undergone an axillary dissection with at least 6 nodes removed and examined or a sentinel node biopsy Patients who are positive by sentinel node biopsy will receive an axillary dissection No locally advanced or inflammatory or metastatic breast cancer Hormone receptor status: Not specified

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/mm3 Platelet count at least 100,000/mm3 Hepatic: Adequate hepatic function Bilirubin no greater than upper limit of normal Renal: Adequate renal function Cardiovascular: Adequate cardiac function Normal MUGA or echocardiogram Other: Not pregnant or nursing Fertile patients must use effective barrier method contraception At least 5 years since prior invasive malignancies, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this malignancy Endocrine therapy: No concurrent tamoxifen Up to 4 weeks of tamoxifen treatment for this malignancy allowed Radiotherapy: No prior radiotherapy for this malignancy Prior radiotherapy to the breast for ductal carcinoma in situ allowed Surgery: Tumor should be removed by either a modified radical mastectomy and/or a segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before beginning treatment on protocol No greater than 84 days since last surgical procedure that constitutes or completes definitive surgical therapy (mastectomy; axillary dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003519

  Show 134 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Investigators
Study Chair: Lori J. Goldstein, MD Fox Chase Cancer Center
Study Chair: Silvana Martino, DO Van Nuys Breast Center
Study Chair: Edith A. Perez, MD Mayo Clinic
Study Chair: Larry Norton, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Goldstein LJ, Gray R, Childs BH, et al.: Prognostic utility of 21-gene assay in hormone receptor (HR) positive operable breast cancer and 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis of Intergroup trial E2197. [Abstract] J Clin Oncol 25 (Suppl 18): A-526, 2007.
Goldstein LJ, O'Neill A, Sparano J, et al.: E2197: Phase III AT (doxorubucin/docetaxel) vs. AC (doxorubicin/cyclophosphamide) in the adjuvant treatment of node positive and high risk node negative breast cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-512, 7s, 2005.
Goldstein LJ, O'Neill A, Sparano JA, et al.: LVEF assessment of adjuvant doxorubicin/cyclophosphamide (AC) vs. doxorubicin/docetaxel (AT) in early stage breast cancer: cardiac safety results of ECOG 2197. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-73, 2003.
Goldstein L, Ravdin P, Gray R, et al.: Prognostic utility of the 21-gene assay compared with adjuvant in hormone receptor (HR) positive operable breast cancer with 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis of intergroup trial E2197. [Abstract] Breast Cancer Res Treat 106 (1): A-63, S17, 2007.

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003519     History of Changes
Other Study ID Numbers: CDR0000066563, E2197, CLB-49802, NCCTG-E2197, SWOG-E2197
Study First Received: November 1, 1999
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
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

ClinicalTrials.gov processed this record on July 22, 2014