drugset / Trial / NCT00002542

Tamoxifen in Treating Women With High-Risk Breast Cancer

NCT00002542

Phase 3 Completed 672 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupTriple-blindTreatment

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. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to study the effectiveness of tamoxifen following surgery and chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or stage II or stage III breast cancer.

Timeline

Start
1993-07-20
Primary completion
2007-03-07
Completion
2011-01-11

Publications

  • Results Bramwell VHC, Pritchard KI, Tu D, et al.: How compliant are patients with oral hormonal therapies? Data from a randomized, placebo controlled study of tamoxifen after adjuvant chemotherapy in premenopausal women with early breast cancer (NCIC CTG MA.12). [Abstract] Breast Cancer Res Treat 106 (1): A-3055, 2007.
  • Results Bramwell VH, Pritchard KI, Tu D, et al.: Tamoxifen (T) compared to placebo (P), after adjuvant chemotherapy (CT), in premenopausal women with early breast cancer (EBC): interim results of NCIC-CTG MA.12. [Abstract] J Clin Oncol 25 (Suppl 18): A-547, 2007.

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule Oral
Background Cyclophosphamide Other / unclassified Oral
Background Doxorubicin Other / unclassified Intravenous
Background Epirubicin Small molecule Intravenous
Background Methotrexate Small molecule
Background fluorouracil Small molecule Intravenous

Indications