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Association details:
| Biomarker: | ER positive |
|---|---|
| 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 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:
...•Age >= 18 years of age•For women: postmenopausal or premenopausal/perimenopausal status:o Age >= 60 yearso Age = 12 months of amenorrhea without an alternative medical cause plus follicle-stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin releasing hormone agonist or antagonisto Documented bilateral oophorectomyo Premenopausal/perimenopausal willing to undergo and maintain treatment with approved LHRH-agonist therapy•For men: willing to undergo and maintain treatment with approved LHRH-agonist therapy•Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent•Disease progression after treatment with one or two lines of systemic therapy in the locally advanced or metastatic setting•Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists guidelines•Documented HER2-negative tumor assessed locally•Confirmed availability of the most recently collected and representative tumor tissue specimen suitable for biomarker testing with de-identified associated pathology report is required. ...
Trial ID:
More C2 evidence
Source:
Title:
Circulating tumor DNA dynamics in acelERA Breast Cancer: a Phase II study of giredestrant for estrogen receptor-positive, HER2-negative, previously treated advanced breast cancer
Published date:
12/02/2023
Excerpt:
The average ESR1 MAF decline on tx with GIR was greater in pts with a PR (–97%) vs PD (–54%, p = 0.025)...Data show that cTF and ESR1m ctDNA dynamics were associated with clinical response to GIR in ER+, HER2– aBC.
Source:
Title:
Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study
Published date:
09/01/2023
Excerpt:
112 patients were evaluable for objective response rate in the giredestrant plus palbociclib group, and 108 were evaluable in the anastrozole plus palbociclib group. Objective response rates were similar between the two groups (56 [50·0%] of 112 [95% CI 40·4–59·6] with giredestrant plus palbociclib vs 53 [49·1%] of 108 [39·3–58·9] with anastrozole plus palbociclib...Giredestrant offers encouraging anti-proliferative and anti-tumour activity and was well tolerated, both as a single agent and in combination with palbociclib.
DOI:
https://doi.org/10.1016/S1470-2045(23)00268-1
Trial ID:
