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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193726
First received: September 11, 2005
Last updated: February 6, 2006
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Ethinyl estradiol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Estrogen Priming to Increase the Efficacy of Standard Adjuvant Chemotherapy in Operable Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Disease Free Survival

Secondary Outcome Measures:
  • Overall Survival

Estimated Enrollment: 1400
Study Start Date: July 2005
Estimated Study Completion Date: December 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193726

Contacts
Contact: Sudeep Gupta, MD, DM + 91 22 24177201 sudeepgupta04@yahoo.com
Contact: Rajendra A Badwe, MS + 91 22 24177000 ext 4264 tmhcrs@vsnl.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rohini Hawaldar    + 91 22 24177000 ext 4265    tmhcrs@vsnl.com   
Contact: Vani Parmar, MS    + 91 22 24177194    vparmar@vsnl.net   
Sub-Investigator: Rajendra A Badwe, MS         
Sub-Investigator: Reena Nair, MD         
Sub-Investigator: Vani Parmar, MS         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sudeep Gupta, MD, DM Tata Memorial Hospital, Mumbai-400012, India
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00193726     History of Changes
Other Study ID Numbers: 122 of 2003
Study First Received: September 11, 2005
Last Updated: February 6, 2006
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
Estrogen
Priming
Adjuvant chemotherapy
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estradiol
Estrogens
Ethinyl Estradiol
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014