NCT00123669

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

22.7 years

First QC Date

July 21, 2005

Last Update Submit

July 21, 2020

Conditions

Breast Neoplasms

Keywords

Cancer of the BreastNeoplasm

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (2)

Control

NO INTERVENTION

Patient will not receive Inj Progesterone 500 mg

Treatment

EXPERIMENTAL

An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.

Drug: 500 mg of depot hydroxy-progesterone

Interventions

500 mg of depot hydroxy-progesteroneDRUG

An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.

Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral operable palpable breast cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (7)

  • 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. doi: 10.1016/0959-8049(94)90415-4.

    PMID: 8018400BACKGROUND

  • 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. doi: 10.1016/0140-6736(91)92927-t.

    PMID: 1674070BACKGROUND

  • 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. doi: 10.1016/0959-8049(95)00301-0.

    PMID: 8652239BACKGROUND

  • 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. doi: 10.1016/s0039-6109(05)70060-8.

    PMID: 10572550BACKGROUND

  • Badwe RA, Hawaldar RW. Effect of menstrual phase on surgical treatment of breast cancer. Lancet. 1994 Aug 6;344(8919):404. No abstract available.

    PMID: 7914322BACKGROUND

  • Badwe RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann Oncol. 1994 Jan;5(1):29-31. doi: 10.1093/oxfordjournals.annonc.a058682. No abstract available.

    PMID: 8172788BACKGROUND

  • Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I. Single-injection depot progesterone before surgery and survival in women with operable breast cancer: a randomized controlled trial. J Clin Oncol. 2011 Jul 20;29(21):2845-51. doi: 10.1200/JCO.2010.33.0738. Epub 2011 Jun 13.

    PMID: 21670457DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rajendra A Badwe, M.S.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

October 1, 1997

Primary Completion

May 29, 2020

Study Completion

May 29, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

IN(1)