Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatment 500 mg of depot hydroxy-progesterone
Phase phase 2/phase 3
Sponsor Tata Memorial Hospital
Collaborator Ministry of Science and Technology, India
Start date October 1997
End date December 2009
Trial size 1000 participants
Trial identifier NCT00123669, No. SP/SO/B29/2000

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Patient will not receive Inj Progesterone 500 mg
(Experimental)
An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.
500 mg of depot hydroxy-progesterone
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.

Primary Outcomes

Measure
To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 75 years old.

Inclusion Criteria: - Unilateral operable palpable breast cancer Exclusion Criteria: - Previous history of excision biopsy of the primary tumour - History of other epithelial/mesenchymal malignant tumours except basal cell carcinoma/squamous cell carcinoma (BCC/SCC) of skin

Additional Information

Official title The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial
Principal investigator Rajendra A Badwe, M.S.
Description This protocol addresses the issue of pre-operative hormone manipulation in women with operable breast cancer. The study has been designed after careful review of literature to assess the effect of unopposed oestrogen at the time of surgery and collect evidence that events at the time of surgery may have impact on the long-term survival of breast cancer patients. The meta-analysis of 37 studies on timing of surgery during the menstrual cycle showed a 15% + 3 improvement in survival for women who had undergone surgery during the luteal phase of their menstrual cycle. Three of the 37 studies where progesterone levels were estimated at the time of surgery showed 52% + 26 improvement in survival when circulating progesterone were > 1.5 ng/ml. The study aims to produce luteal milieu by injecting Hydroxy- progesterone 500 mg IM at the time of surgery. The timing of administration of progesterone in the neo-adjuvant setting is decided after collating data from large data-bases and randomised trials of screening suggesting that events at the time of surgery may alter the behavior of micro-metastases.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Tata Memorial Hospital.