Overview

Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
Female
Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
Cancer Research Campaign Clinical Trials Centre
Scottish Cancer Therapy Network
Yorkshire Regional Clinical Trials Research Unit
Treatments:
Cyclophosphamide
Doxorubicin
Fluorouracil
Goserelin
Leuprolide
Liposomal doxorubicin
Methotrexate
Tamoxifen
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic
therapy is appropriate

- Stage I, II, or IIIA

- Pathologically positive or negative nodes

- Any size primary tumor

- No edema, peau d'orange, infiltration of the skin, or direct extension to the chest
wall

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- Not specified

Sex:

- Female

Menopausal status:

- Pre-, peri-, or postmenopausal

Performance status:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No prior malignancy except:

- Basal cell carcinoma

- Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No prior systemic treatment for breast cancer