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Primary Progesterone Therapy for Operable Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123669
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Centre

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 25, 2005
Last Update Posted Date July 22, 2020
Study Start Date  ICMJE October 1997
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: July 21, 2005)
To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Progesterone Therapy for Operable Breast Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2005)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 29, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123669
Other Study ID Numbers  ICMJE No. SP/SO/B29/2000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Rajendra A. Badwe, Tata Memorial Centre
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE Ministry of Science and Technology, India
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP