Estrogen Priming to Increase the Efficacy of Adjuvant Chemotherapy in Operable Breast Cancer

• Status: Terminated
• Trial end date: 2012-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

One of the basic principles of cancer chemotherapy is that these drugs act exclusively or mainly on cells in cycle. Estrogens have been shown to increase the fraction of breast cancer cells in cycle. Tamoxifen on the other hand, decreases the proliferative fraction and has been shown to negatively impact on the results of adjuvant chemotherapy in breast cancer when given concomitantly. A number of previous studies have attempted estrogenic recruitment of cancer cells (into cell cycle) to increase the efficacy of chemotherapy in locally advanced and metastatic breast cancer. Although some studies showed an increase in response rates in the recruitment arm, there was no benefit in time to progression or survival in any of the studies. These results may have been due to the inadequate sample size of the studies and advanced stage disease (with presumably higher fraction of inherently chemoresistant cells). The present study is designed to test the hypothesis that estrogenic recruitment of micrometastatic disease in operable breast cancer will increase the efficacy of standard adjuvant chemotherapy after surgery. The intervention arm of the study will involve administration of short duration estrogen prior to each cycle of adjuvant chemotherapy. The end-points are disease free and overall survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sudeep Gupta
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Estrogens, Conjugated (USP); Ethinyl Estradiol; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 1. Patients with histological or cytologic proof of breast cancer. 2. Patients with operable breast cancer. 3. Patients who are candidates for adjuvant chemotherapy according to the standard policy. 4. Patients who have no contraindication to anthracycline based chemotherapy. 5. Patients who give informed consent to participate in the study. 6. Patients who can be followed up and can take all cycles of chemotherapy at the participating institution. 7. Patients should not have a known second cancer, present or past.

Exclusion Criteria:

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