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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | lerociclib (G1T38) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy.
Published date:
05/25/2023
Excerpt:
In patients with measurable disease (n=240, 87.3%), the ORR was significantly higher in lerociclib + F 26.9% (2.5% complete response [CR]) vs 9.9% (0% CR) for P + F….Lerociclib at 150mg twice daily plus fulvestrant significantly improved PFS and ORR and demonstrated a favorable tolerable safety profile in pts with HR+ / HER2- endocrine-resistant advanced BC.
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2023.41.16_suppl.1017
Trial ID:
Source:
Title:
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Excerpt:
...- Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer;...
Trial ID:
Source:
Title:
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- Confirmed diagnosis of HR-positive, HER2-negative breast cancer,...
Trial ID:
Less C2 evidence
Source:
Title:
334P - Lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients: Updated phase II results and dose selection
Published date:
07/14/2020
Excerpt:
This phase I/II study assessed lerociclib with 500 mg F in patients (pts) with HR+/HER2- ABC....Six pts (32%) had a confirmed PR; 9 (47%) had SD; 4 (21%) had PD. The CBR (CR+PR+SD ≥ 24 weeks) was 74% (14/19).
Secondary therapy:
fulvestrant
Trial ID:
