NCT00123669|CompletedPhase 2/3
Primary Progesterone Therapy for Operable Breast Cancer
The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial
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The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial
Sponsor study identifier
interventional
1,000
1 country
1
Study Start
October 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 29, 2020
Actual (reported)Study Completion
May 29, 2020
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 29, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1997
Date type not reportedThis date has not been verified as actual or estimated.
July 21, 2005
Actual (reported)July 25, 2005
Actual (reported)May 29, 2020
Actual (reported)May 29, 2020
Actual (reported)To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years
5 years
Patient will not receive Inj Progesterone 500 mg
An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
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. doi: 10.1016/0959-8049(94)90415-4.
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. doi: 10.1016/0140-6736(91)92927-t.
Rajendra A Badwe, M.S.
Professor & Head, Department of Surgical Oncology, Chief Breast Unit
1,000 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2005
First Posted
July 25, 2005
Study Start
October 1997
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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. doi: 10.1016/0959-8049(95)00301-0.
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. doi: 10.1016/s0039-6109(05)70060-8.
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. doi: 10.1093/oxfordjournals.annonc.a058682. No abstract available.
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.
Primary Completion
May 29, 2020
Actual (reported)Study Completion
May 29, 2020
Actual (reported)Last Updated
July 22, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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