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

NCT00193726 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2018-09-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tab Premarin (Ethinyl estradiol)

Tab Premarin 0.625 mg (Ethinyl estradiol) once a day for 5 days prior to each cycle of chemotherapy

DRUG

Placebo

Placebo once a day for 5 days prior to each cycle of chemotherapy

Sponsors & Collaborators

  • Sudeep Gupta

    lead OTHER_GOV

Principal Investigators

  • Sudeep Gupta, MD, DM · Tata Memorial Hospital, Mumbai-400012, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2012-03-30
Completion
2012-03-30

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193726 on ClinicalTrials.gov