# Single-injection depot progesterone before breast surgery (Tata Memorial)

Source: https://onco.cc/trials/progesterone-preop-tmh/  
OnCo record `progesterone-preop-tmh` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A single cheap hormone injection before breast surgery did not help every woman, but in those whose cancer had reached the lymph nodes it improved survival at five years, a finding still being tested.

## Summary

976 women with operable breast cancer were randomised to a single preoperative injection of depot hydroxyprogesterone or no injection, with a median follow-up of 65 months. Disease-free survival and overall survival were not significantly improved overall, but in node-positive patients 5-year disease-free survival was 65.3% versus 54.7% (hazard ratio 0.72; 95% CI 0.54-0.97; P=0.02) and overall survival 75.7% versus 66.8% (hazard ratio 0.70; 95% CI 0.49-0.99; P=0.04). Badwe and colleagues concluded that a simple, inexpensive intervention deserved confirmation; the same group's later randomised trial of peritumoral lidocaine at surgery (1,583 women) did show a survival gain, keeping the perioperative window a live research theme in India.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-10
- Phase: 3
- Setting: Operable breast cancer: one intramuscular injection of hydroxyprogesterone 5 to 14 days before surgery vs no injection
- Sponsor: Tata Memorial Centre
- Enrolled: 976
- Result: No overall benefit; node-positive 5-year DFS 65.3% vs 54.7% (HR 0.72) and OS 75.7% vs 66.8% (HR 0.70).
- Outcomes: 5-year disease-free survival, node-positive subgroup: Progesterone 65.3% vs Control 54.7%, HR 0.72

## Sources

- Badwe et al., JCO 2011: https://doi.org/10.1200/JCO.2010.33.0738

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- institutions: [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- trials: [Peritumoral lidocaine before breast cancer surgery (Tata Memorial)](https://onco.cc/trials/lidocaine-peritumoral-tmh/)
- people: [Rajendra Badwe](https://onco.cc/people/badwe-rajendra/)
- bottlenecks: [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/), [Surgery and radiotherapy cure most, get least](https://onco.cc/bottlenecks/b-surgery-radiation-innovation/)
- key papers: [Single-injection depot progesterone before surgery and survival in operable breast cancer](https://onco.cc/key-papers/paper-badwe-progesterone-jco-2011/)
- terms: [Pre-specified vs post-hoc analysis](https://onco.cc/terms/prespecified-vs-post-hoc/), [Subgroup analysis (forest plots)](https://onco.cc/terms/subgroup-analysis/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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