{"entity":{"id":"progesterone-preop-tmh","kind":"trial","name":"Single-injection depot progesterone before breast surgery (Tata Memorial)","aka":[],"tldr":"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.","status":"mixed","asOf":"2026-09-10","links":[{"label":"Badwe et al., JCO 2011","url":"https://doi.org/10.1200/JCO.2010.33.0738"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":["lidocaine-peritumoral-tmh"],"people":["badwe-rajendra"],"bottlenecks":["b-generic-repurposing","b-surgery-radiation-innovation"],"keyPapers":["paper-badwe-progesterone-jco-2011"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable breast cancer: one intramuscular injection of hydroxyprogesterone 5 to 14 days before surgery vs no injection","sponsor":"Tata Memorial Centre","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).","yearReported":2011,"enrolled":976,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year disease-free survival, node-positive subgroup","unit":"%","arms":[{"name":"Progesterone","value":65.3},{"name":"Control","value":54.7}],"hr":0.72,"ci":[0.54,0.97],"p":"0.02","source":"https://doi.org/10.1200/JCO.2010.33.0738"}]},"route":"/trials/progesterone-preop-tmh/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"institution":[{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"trial":[{"id":"lidocaine-peritumoral-tmh","kind":"trial","name":"Peritumoral lidocaine before breast cancer surgery (Tata Memorial)","route":"/trials/lidocaine-peritumoral-tmh/"}],"person":[{"id":"badwe-rajendra","kind":"person","name":"Rajendra Badwe","route":"/people/badwe-rajendra/"}],"bottleneck":[{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"}],"paper":[{"id":"paper-badwe-progesterone-jco-2011","kind":"paper","name":"Single-injection depot progesterone before surgery and survival in operable breast cancer","route":"/key-papers/paper-badwe-progesterone-jco-2011/"}],"term":[{"id":"prespecified-vs-post-hoc","kind":"term","name":"Pre-specified vs post-hoc analysis","route":"/terms/prespecified-vs-post-hoc/"},{"id":"subgroup-analysis","kind":"term","name":"Subgroup analysis (forest plots)","route":"/terms/subgroup-analysis/"},{"id":"trial-failure-modes","kind":"term","name":"Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover","route":"/terms/trial-failure-modes/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}