Primary Progesterone Therapy for Operable Breast
Cancer
This study is no longer recruiting
patients.
| 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:
- 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: Depot preparation of
Hydroxyprogesterone hexanoate 500mg
|
Phase
III
|
MedlinePlus related
topics: Breast Cancer
Genetics
Home Reference related topics: breast cancer
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
Further study details as provided by Tata Memorial
Hospital:
Primary Outcomes: To test the effect of primary
progesterone in operable breast cancer on overall and disease free survival at 5
years
Expected Total Enrollment: 1000
Study start: 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% + 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 - 75 Years, Genders Eligible for Study: Female
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
Location Information
India, Maharashtra Tata
Memorial Hospital, Mumbai, Maharashtra, 400012, India
Study chairs or principal investigators
Rajendra A Badwe, M.S., Principal
Investigator, Professor & Head, Department of Surgical Oncology, Chief
Breast Unit
More Information
Publications
Badwe
RA, Wang DY, Gregory WM, Fentiman IS, Chaudary MA, Smith P, Richards MA, Rubens
RD. Serum progesterone at the time of surgery and survival in women with
premenopausal operable breast cancer. Eur J Cancer. 1994;30A(4):445-8.
Badwe
RA, Gregory WM, Chaudary MA, Richards MA, Bentley AE, Rubens RD, Fentiman IS.
Timing of surgery during menstrual cycle and survival of premenopausal women
with operable breast cancer. Lancet. 1991 May 25;337(8752):1261-4.
Badwe
RA, Bettelheim R, Millis RR, Gregory W, Richards MA, Fentiman IS. Cyclical
tumour variations in premenopausal women with early breast cancer. Eur J Cancer.
1995 Dec;31A(13-14):2181-4.
Badwe
RA, Mittra I, Havaldar R. Timing of surgery with regard to the menstrual cycle
in women with primary breast cancer. Surg Clin North Am. 1999 Oct;79(5):1047-59.
Review.
Badwe
RA, Hawaldar RW. Effect of menstrual phase on surgical treatment of breast
cancer. Lancet. 1994 Aug 6;344(8919):404. No abstract available.
Badwe
RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann
Oncol. 1994 Jan;5(1):29-31. No abstract available.
Study ID Numbers: No. SP/SO/B29/2000
Last
Updated: August 1, 2005
Record first received: July 21,
2005
ClinicalTrials.gov Identifier:
NCT00123669Health
Authority: India: Science and Engineering Research Council
ClinicalTrials.gov processed this record on 2006-11-28
