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The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Rajendra A Badwe, M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor & Head, Department of Surgical Oncology, Chief Breast Unit


India: Science and Engineering Research Council

Study ID:

No. SP/SO/B29/2000



Start Date:

October 1997

Completion Date:

December 2017

Related Keywords:

  • Breast Neoplasms
  • Cancer of the Breast
  • Neoplasm
  • Breast Neoplasms
  • Neoplasms