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Primary Progesterone Therapy for Operable Breast Cancer - Article


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Progesterone

 



Clinical Trial: Primary Progesterone Therapy for Operable Breast Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Tata Memorial Hospital
Ministry Of Science and Technology, Government of India
Information provided by: Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00123669

Purpose

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:

Condition Intervention Phase
Breast Neoplasms
  Drug: Depot preparation of Hydroxyprogesterone hexanoate 500mg
 Phase III

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years
Expected Total Enrollment:  1000

Study start: October 1997

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

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

Exclusion Criteria:

Location Information


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

Study chairs or principal investigators

Rajendra A Badwe, M.S.,  Principal Investigator,  Professor & Head, Department of Surgical Oncology, Chief Breast Unit   

More Information

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. No abstract available.

Badwe RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann Oncol. 1994 Jan;5(1):29-31. No abstract available.

Study ID Numbers:  No. SP/SO/B29/2000
Last Updated:  August 1, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123669
Health Authority: India: Science and Engineering Research Council
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005

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Page Updated: June 1, 2005
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