Primary Progesterone Therapy for Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00123669|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2005
Last Update Posted : January 17, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: 500 mg of depot hydroxy-progesterone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial|
|Study Start Date :||October 1997|
|Actual Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2019|
No Intervention: Control
Patient will not receive Inj Progesterone 500 mg
An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.
Drug: 500 mg of depot hydroxy-progesterone
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
- To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123669
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Rajendra A Badwe, M.S.||Professor & Head, Department of Surgical Oncology, Chief Breast Unit|