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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

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)

Excerpt:
...- Documented ER-positive tumor and HER2-negative tumor, assessed locally...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
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.
Evidence Level:
Sensitive: C3 – Early Trials
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: