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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Tata Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Sudeep Gupta, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193726
First received: September 11, 2005
Last updated: October 25, 2016
Last verified: October 2016
  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: Tab Premarin (Ethinyl estradiol)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Duration in months between Date of randomization and date of first disease progression


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 60 Months ] [ Designated as safety issue: No ]
    Duration in months between Date of randomization and date of death by any cause disease progression


Estimated Enrollment: 730
Study Start Date: July 2005
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm B- Experimental
Tab Premarin 0.625 mg (Ethinyl estradiol) once a day for 5 days prior to each cycle of chemotherapy
Drug: Tab Premarin (Ethinyl estradiol)
Tab Premarin 0.625 mg (Ethinyl estradiol) once a day for 5 days prior to each cycle of chemotherapy
Other Name: Tab Premarin
Placebo Comparator: Arm A - Placebo
Tab Placebo 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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    hawaldarrw@tmc.gov.in   
Contact: Vani Parmar, MS    + 91 22 24177194    vaniparmar@gmail.com   
Sub-Investigator: Rajendra A Badwe, MS         
Sub-Investigator: Reena Nair, MD         
Sub-Investigator: Vani Parmar, MS         
Sponsors and Collaborators
Sudeep Gupta
Investigators
Principal Investigator: Sudeep Gupta, MD, DM Tata Memorial Hospital, Mumbai-400012, India
  More Information

Responsible Party: Sudeep Gupta, Professor of medical oncology, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00193726     History of Changes
Other Study ID Numbers: 122 of 2003 
Study First Received: September 11, 2005
Last Updated: October 25, 2016
Health Authority: India: Department of Atomic Energy
Individual Participant Data  
Plan to Share IPD: Undecided

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
Polyestradiol phosphate
Estrogens
Estrogens, Conjugated (USP)
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on December 09, 2016