{"entity":{"id":"giredestrant","kind":"drug","name":"Giredestrant","aka":[],"tldr":"Giredestrant is Roche's oral SERD: it failed to beat an aromatase inhibitor in first-line metastatic disease but succeeded after surgery and after CDK4/6 failure.","summary":"evERA (with everolimus after CDK4/6): PFS HR 0.56, HR 0.38 in ESR1-mutant; NDA accepted February 2026. lidERA (adjuvant): ~30% fewer invasive recurrences than standard endocrine therapy (SABCS 2025). persevERA (first-line with palbociclib): missed its primary endpoint (March 2026). Together these define where oral SERDs add value: resistance and adjuvant settings rather than upfront in unselected metastatic disease.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05306340 (evERA)","url":"https://clinicaltrials.gov/study/NCT05306340"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["oral-serd"],"trials":["evera","lidera","persevera","nct07100106","nct06065748","nct05296798","nct07541079","nct04576455","nct07054190"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"GDC-9545, RG6171","modality":"Oral SERD","mechanism":"Oral SERD with full ER antagonism and degradation.","approvals":[],"mechanismSteps":[],"dosing":{"route":"Oral","schedule":"30 mg once daily (trial dose)"},"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-02-19","type":"filing","region":"US","note":"NDA accepted (evERA, ESR1-mutant)","source":"https://www.gene.com/media/press-releases/15100/2026-02-19/fda-accepts-new-drug-application-for-gen"},{"date":"2026-03-09","type":"designation","region":"Global","note":"persevERA primary endpoint not met","source":"https://www.roche.com/media/releases/med-cor-2026-03-09"}]},"route":"/drugs/giredestrant/","neighbours":{"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"oral-serds","kind":"technology","name":"Oral SERDs","route":"/technologies/oral-serds/"}],"target":[{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"oral-serd","kind":"term","name":"Oral SERD","route":"/terms/oral-serd/"}],"trial":[{"id":"nct07541079","kind":"trial","name":"A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)","route":"/trials/nct07541079/"},{"id":"nct04576455","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)","route":"/trials/nct04576455/"},{"id":"nct04802759","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","route":"/trials/nct04802759/"},{"id":"nct06065748","kind":"trial","name":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","route":"/trials/nct06065748/"},{"id":"nct07100106","kind":"trial","name":"A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","route":"/trials/nct07100106/"},{"id":"nct05296798","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)","route":"/trials/nct05296798/"},{"id":"nct07054190","kind":"trial","name":"A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer","route":"/trials/nct07054190/"},{"id":"evera","kind":"trial","name":"evERA","route":"/trials/evera/"},{"id":"lidera","kind":"trial","name":"lidERA","route":"/trials/lidera/"},{"id":"persevera","kind":"trial","name":"persevERA","route":"/trials/persevera/"}],"idea":[{"id":"idea-late-recurrence-interception","kind":"idea","name":"Intercepting late recurrence with ctDNA surveillance and oral SERDs","route":"/ideas/idea-late-recurrence-interception/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}