Primary Progesterone Therapy for Operable Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: 500 mg of depot hydroxy-progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patient will not receive Inj Progesterone 500 mg | |
| Experimental: Treatment<br>An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery. | Drug: 500 mg of depot hydroxy-progesterone<br>* An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of the Breast, Neoplasm