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Primary Progesterone Therapy for Operable Breast Cancer

NCT00123669 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2020-07-22

No results posted yet for this study

Summary

The purpose of this study is to test the effect of primary progesterone on overall and disease free survival in women with operable breast cancer. The study addresses two issues related to breast cancer surgery:

* Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer.
* Events at the time of surgery may have an impact on the natural history of breast cancer

Conditions

  • Breast Neoplasms

Interventions

DRUG

500 mg of depot hydroxy-progesterone

An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Rajendra A Badwe, M.S. · Professor & Head, Department of Surgical Oncology, Chief Breast Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1997-10-31
Primary Completion
2020-05-29
Completion
2020-05-29

Countries

  • India

Study Locations

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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 NCT00123669 on ClinicalTrials.gov