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Primary Progesterone Therapy for Operable Breast Cancer

Information source: Tata Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: 500 mg of depot hydroxy-progesterone (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Tata Memorial Hospital

Official(s) and/or principal investigator(s):
Rajendra A Badwe, M.S., Principal Investigator, Affiliation: Professor & Head, Department of Surgical Oncology, Chief Breast Unit

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Tata Memorial Hospital, Mumbai, Maharashtra 400012, India
Additional Information

Related publications:

Badwe RA, Wang DY, Gregory WM, Fentiman IS, Chaudary MA, Smith P, Richards MA, Rubens RD. Serum progesterone at the time of surgery and survival in women with premenopausal operable breast cancer. Eur J Cancer. 1994;30A(4):445-8.

Badwe RA, Gregory WM, Chaudary MA, Richards MA, Bentley AE, Rubens RD, Fentiman IS. Timing of surgery during menstrual cycle and survival of premenopausal women with operable breast cancer. Lancet. 1991 May 25;337(8752):1261-4.

Badwe RA, Bettelheim R, Millis RR, Gregory W, Richards MA, Fentiman IS. Cyclical tumour variations in premenopausal women with early breast cancer. Eur J Cancer. 1995 Dec;31A(13-14):2181-4.

Badwe RA, Mittra I, Havaldar R. Timing of surgery with regard to the menstrual cycle in women with primary breast cancer. Surg Clin North Am. 1999 Oct;79(5):1047-59. Review.

Badwe RA, Hawaldar RW. Effect of menstrual phase on surgical treatment of breast cancer. Lancet. 1994 Aug 6;344(8919):404.

Badwe RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann Oncol. 1994 Jan;5(1):29-31.

Starting date: October 1997
Last updated: June 23, 2014

Page last updated: August 23, 2015

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