NOV 30 2026
Genentech — giredestrant $RHHBY
for adjuvant treatment of ER-positive, HER2-negative, stage I-III breast cancer
Accepted JUN 2 2026.
About
Breast cancer is a disease where abnormal cells grow in breast tissue and can spread to other parts of the body, causing serious complications. Giredestrant is an oral drug designed to block the estrogen receptor, a key protein that fuels the growth of this specific cancer type. By directly interfering with this growth signal, it could potentially help prevent the cancer from returning after initial surgery.
Pivotal trial
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on giredestrant
- Roche Boasts Full Late-Stage Pipeline as it Awaits Key Giredestrant FDA Decisions - Precision Medicine Online
- Giredestrant Plus Palbociclib Yields Numerical PFS Benefit in ER+, HER2– Advanced Breast Cancer - OncLive
- Dr Mardones on Giredestrant Plus Palbociclib in Estrogen Receptor+ Breast Cancer - OncLive
- HR-Positive/HER2-Negative Early Breast Cancer: Emerging Endocrine Strategies and the Potential Role of Giredestrant - OncLive
- Giredestrant Plus Everolimus Shows Survival Benefits in Advanced Breast Cancer - Oncology News Central
Sponsor Watch — recent news on Genentech
- FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting
- FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting