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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:
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Excerpt:
...- ER-positive tumor and HER2-negative breast cancer as per local laboratory testing...
Trial ID:
Source:
Title:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
Excerpt:
...- Documented estrogen receptor (ER)-positive tumor in accordance to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al.2020), assessed locally and defined as ≥1% of tumor cells stained positive on the basis of the most recent tumor biopsy...
Trial ID:
Source:
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:
Source:
Title:
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
Excerpt:
...- Estrogen receptor (ER)-positive tumor...
Trial ID:
Source:
Title:
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
Excerpt:
...Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally 3....
Trial ID:
Source:
Title:
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Excerpt:
...- Documented ER-positive tumor and HER2-negative tumor, assessed locally...
Trial ID:
Source:
Title:
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
Excerpt:
...- Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen...
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:
...- Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)...
Trial ID:
Source:
Title:
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
Excerpt:
...- Documented estrogen receptor (ER)-positive tumor in accordance to ASCO/CAP guidelines (Allison et al....
Trial ID:
Less 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:
