NCT00193726

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jul 2005

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2012

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

6.8 years

First QC Date

September 11, 2005

Last Update Submit

September 18, 2018

Conditions

Breast Cancer

Keywords

EstrogenPrimingAdjuvant chemotherapyBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival

    Duration in months between Date of randomization and date of first disease progression

    60 months

Secondary Outcomes (1)

  • Overall Survival

    60 Months

Study Arms (2)

Arm B- Experimental

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)

Arm A - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tab Premarin (Ethinyl estradiol)DRUG

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

Also known as: Tab Premarin
Arm B- Experimental
PlaceboDRUG

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

Arm A - Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estrogens, Conjugated (USP)Ethinyl Estradiol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, Alkylated

Study Officials

  • Sudeep Gupta, MD, DM

    Tata Memorial Hospital, Mumbai-400012, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of medical oncology

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

July 1, 2005

Primary Completion

March 30, 2012

Study Completion

March 30, 2012

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

IN(1)