Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Resp… (NCT00066703) | Clinical Trial Compass
CompletedPhase 3
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
United States2,672 participantsStarted 2003-11-03
Plain-language summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Completely resected disease
* No clinically detectable residual loco-regional axillary disease
* Prior surgery for primary breast cancer of 1 of the following types:
* Total mastectomy with or without adjuvant radiotherapy
* Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative\* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: \*If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
* Tumor confined to the breast and axillary nodes
* Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed
* Axillary lymph node dissection or a negative axillary sentinel node biopsy required
* Patients with negative or microscopically positive axillary sentinel nodes are eligible
* Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes
* No distant metastases
* No locally advanced inoperable breast cancer, including any of the following:
* Inflammatory breast cancer
* Supraclavicular node involvement
* Enlarged internal mammary nodes (unless pathologically negative)
* Bilateral synchronous invasive breast cance…
What they're measuring
1
Disease-free Survival
Timeframe: 5-year estimate reported at a median follow-up of 72 months