# Giredestrant

Source: https://onco.cc/drugs/giredestrant/  
OnCo record `giredestrant` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Code: GDC-9545, RG6171
- Modality: Oral SERD
- Mechanism: Oral SERD with full ER antagonism and degradation.
- Dosing: Oral; 30 mg once daily (trial dose)

## Sources

- ClinicalTrials.gov NCT05306340 (evERA): https://clinicaltrials.gov/study/NCT05306340

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/), [Oral SERDs](https://onco.cc/technologies/oral-serds/)
- targets: [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Oral SERD](https://onco.cc/terms/oral-serd/)
- trials: [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)](https://onco.cc/trials/nct07541079/), [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)](https://onco.cc/trials/nct04576455/), [A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer](https://onco.cc/trials/nct04802759/), [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)](https://onco.cc/trials/nct06065748/), [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](https://onco.cc/trials/nct07100106/), [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)](https://onco.cc/trials/nct05296798/), [A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer](https://onco.cc/trials/nct07054190/), [evERA](https://onco.cc/trials/evera/), [lidERA](https://onco.cc/trials/lidera/), [persevERA](https://onco.cc/trials/persevera/)
- ideas: [Intercepting late recurrence with ctDNA surveillance and oral SERDs](https://onco.cc/ideas/idea-late-recurrence-interception/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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