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| Sponsors and Collaborators: |
Tata Memorial Hospital Ministry of Science and Technology, 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 |
| 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 |
| Estimated Enrollment: | 1000 |
| Study Start Date: | 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%
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| India, Maharashtra | |
| Tata Memorial Hospital | |
| Mumbai, Maharashtra, India, 400012 | |
| Principal Investigator: | Rajendra A Badwe, M.S. | Professor & Head, Department of Surgical Oncology, Chief Breast Unit |
More Information
| Study ID Numbers: | No. SP/SO/B29/2000 |
| Study First Received: | July 21, 2005 |
| Last Updated: | August 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00123669 History of Changes |
| Health Authority: | India: Science and Engineering Research Council |
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Cancer of the Breast Neoplasm |
|
Estrogen Antagonists Estrogens Skin Diseases Progesterone Hormone Antagonists Caproate Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Estradiol 17 beta-cypionate Hormones 17-alpha-hydroxy-progesterone caproate Estradiol Estrogen Receptor Modulators Progestins Estradiol 3-benzoate Polyestradiol phosphate Breast Diseases |
|
Estrogen Antagonists Skin Diseases Progesterone Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Hormones |
17-alpha-hydroxy-progesterone caproate Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Progestins Breast Diseases Estradiol Antagonists |