Primary Progesterone Therapy for Operable Breast Cancer

• ClinicalTrials.gov Identifier: NCT00123669
• Recruitment Status: Completed
• First Posted: July 25, 2005
• Last Update Posted: July 22, 2020
• Sponsor: Tata Memorial Hospital
• Collaborator: Ministry of Science and Technology, India
• Information provided by (Responsible Party): Dr Rajendra A. Badwe, Tata Memorial Centre

Tracking Information

• First Submitted Date: July 21, 2005
• First Posted Date: July 25, 2005
• Last Update Posted Date: July 22, 2020
• Study Start Date: October 1997
• Actual Primary Completion Date: May 29, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 17, 2011): To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: July 21, 2005): To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Neoplasms

Intervention

Drug: 500 mg of depot hydroxy-progesterone

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

Study Arms

• No Intervention: Control
  Patient will not receive Inj Progesterone 500 mg
• Experimental: Treatment
  An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.
  Intervention: Drug: 500 mg of depot hydroxy-progesterone

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.
• Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I. Single-injection depot progesterone before surgery and survival in women with operable breast cancer: a randomized controlled trial. J Clin Oncol. 2011 Jul 20;29(21):2845-51. doi: 10.1200/JCO.2010.33.0738. Epub 2011 Jun 13.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2005): 1000
• Original Enrollment: Same as current
• Actual Study Completion Date: May 29, 2020
• Actual Primary Completion Date: May 29, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00123669
• Other Study ID Numbers: No. SP/SO/B29/2000
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr Rajendra A. Badwe, Tata Memorial Centre
• Study Sponsor: Tata Memorial Hospital
• Collaborators: Ministry of Science and Technology, India

Investigators

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

• PRS Account: Tata Memorial Hospital
• Verification Date: July 2020