NCT00123669

Primary Progesterone Therapy for Operable Breast Cancer

The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Breast Neoplasms

Interventions

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

Timeline

• Start date: 1997-10-01
• Primary completion: 2020-05-29
• Completion: 2020-05-29
• First posted: 2005-07-25
• Last updated: 2020-07-22

Locations

1 site across 1 country: India