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Association details:
| Biomarker: | ER mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | giredestrant (GDC-9545) (Estrogen receptor antagonist, Selective estrogen receptor degrader) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study to Evaluate the Efficacy and Safety of Giredestrant Plus Everolimus Compared with Exemestane Plus Everolimus in Patients with Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Estudio para Evaluar la Eficacia y la Seguridad de la Combinación Giredestrant Más Everólimus, Y Compararlas con las de la Combinación Exemestano Más Everólimus, en Pacientes con Cáncer de Mama con Receptores Estrogénicos, sin Mutación Del Gen Her2, Localmente Avanzado o Metastásico
Excerpt:
...● Age >= 18 years● Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent● Documented estrogen receptor-positive (ER+) tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society for Medical Oncology (ESMO) guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy (or archived tumor sample)● Documented human epidermal growth factor receptor 2 (HER2)-negative tumor assessed locally● Availability of blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) ESR1 mutation status determination by central testing prior to study treatment randomization● Patients who have bilateral breast cancers that are both ER+ and HER2-negative are eligible. ...
Trial ID:
Source:
Title:
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)
Excerpt:
...- Confirmed ESR1 mutation status (ESR1m vs....
Trial ID:
More C2 evidence
Source:
Title:
A Study to Evaluate the Efficacy and Safety of GDC-9545 Compared with Physician's Choice of Endocrine Monotherapy in Patients with Previously Treated Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Excerpt:
...Investigator-assessed progression free survival n subgroups categorized by baseline ESR1 mutation status6. ...
Trial ID:
Less C2 evidence
Source:
Title:
PD13-04 Exploratory subgroup and biomarker analyses of acelERA Breast Cancer: Phase II study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy for previously treated, estrogen receptor+, HER2– advanced breast cancer
Published date:
11/22/2022
Excerpt:
Patients were post- and pre- or peri-menopausal women, or men, with ER+, HER2– aBC...Randomization was 1:1 to giredestrant (30 mg oral daily) or PCET between fulvestrant or an aromatase inhibitor...Exploratory subgroup analyses showed favorable outcomes with giredestrant in terms of INVPFS, CBR, and ORR across most key subgroups. The benefit was more pronounced in a) patients with ESR1-mutated tumors...
Trial ID:
Source:
Title:
211MO - Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase II, randomised, open-label acelERA BC study
Published date:
09/05/2022
Excerpt:
A higher CBR and ORR was also observed in favour of giredestrant. In pts with higher dependence on ER activity, such as those with ESR1 mutations, the PFS benefit was more pronounced. Giredestrant was well tolerated, with a safety profile comparable to PCET and consistent with known ET risks.
Trial ID:
Source:
Title:
Roche presents data on giredestrant, a next generation selective oestrogen receptor degrader for people with hormone receptor-positive, HER-2 negative breast cancer
Published date:
06/04/2021
Excerpt:
...phase I study in the locally advanced/metastatic breast cancer setting showed that giredestrant as a monotherapy was well-tolerated, and had promising clinical activity....the presence of ESR1 mutations...and clinical benefit rates of 55% and 76% were observed in the overall and ESR1 mutant subgroups, respectively.
Trial ID:
