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Primary Progesterone Therapy for Operable Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by Tata Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00123669
First received: July 21, 2005
Last updated: October 28, 2011
Last verified: April 2005
History of Changes
  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:

  • 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 Intervention Phase
Breast Neoplasms
 Drug: 500 mg of depot hydroxy-progesterone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: October 1997
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: 500 mg of depot hydroxy-progesterone
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123669

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Ministry of Science and Technology, India
Investigators
Principal Investigator: Rajendra A Badwe, M.S. Professor & Head, Department of Surgical Oncology, Chief Breast Unit
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr R A Badwe, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00123669     History of Changes
Other Study ID Numbers: No. SP/SO/B29/2000
Study First Received: July 21, 2005
Last Updated: October 28, 2011
Health Authority: India: Science and Engineering Research Council

Keywords provided by Tata Memorial Hospital:
Cancer of the Breast
Neoplasm

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013