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Association details:
| Biomarker: | ESR1 mutation + HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Fulvestrant-palbociclib vs continuing aromatase inhibitor-palbociclib upon detection of circulating ESR1 mutation in HR+ HER2- metastatic breast cancer patients: Results of PADA-1, a UCBG-GINECO randomized phase 3 trial
Published date:
10/09/2021
Excerpt:
PADA-1 (NCT03079011), a multicenter, randomized, open-label, phase 3 trial, enrolled HR+ HER2- mBC pts with no prior therapy for mBC...Among the 172 randomized pts, N=136 PFS events have been observed in the second step after a median follow-up of 26 months. The median PFS was 5.7 months (95%CI[3.9;7.5]) in the AI-palbociclib arm and 11.9 months (95%CI[9.1;13.6]) in the fulvestrant-palbociclib arm (HR=0.63; 95%CI|0.45-0.88], p=0.007).
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving the Cyclin-Dependent Kinase 4/6 Inhibitor Palbociclib: Biomarker Results from POLARIS
Published date:
11/22/2022
Excerpt:
CONTRADICTING EVIDENCE: POLARIS is a prospective, real-world study of palbociclib in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC) in the United States and Canada....Patients in the biomarker analysis group provided consent for serial blood sample collection, received ≥1 dose of initial palbociclib combination treatment...Patients with mutated ESR1 and PIK3CA or CCND1 and FGFR1 amp at baseline had shorter rwPFS than patients with wild-type genes .
Trial ID:
Test:
