Primary Progesterone Therapy for Operable Breast Cancer

Tata Memorial Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: 500 mg of depot hydroxy-progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT00123669

No. SP/SO/B29/2000

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Control

No Intervention group

Description:

Patient will not receive Inj Progesterone 500 mg

Treatment

Experimental group

Description:

An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.

Treatment:

Drug: 500 mg of depot hydroxy-progesterone