Metastatic Breast Cancer Combination - Europe PMC

The Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast Cancer.

Purpose HER2 mutations cause endocrine disruption in estrogen receptor-positive breast cancer. Patients with ER+/HER2mut, HER2 non-amplified metastatic breast cancer in the fulvestrant-treated or fulvestrant-nave cohort in this single-arm multi-cohort phase II trial. In an exploratory ER-group study, patients with ER-negative /HER2mut MBC received neratinib monotherapy. HER2mut MBC's treatment has been confirmed by our findings.

Source link: https://europepmc.org/article/MED/35046057

Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1.

Introduction The combination of a CDK4/6 inhibitor with an aromatase inhibitor has recently become the gold standard for AI-sensitive first-line therapy of oestrogen receptor-positive advanced breast cancer with an oestrogen receptor-positive HER2-negative first line therapy. When considering global safety, our research investigates whether routine monitoring for emerging or increasing ESR1 mutations in ctDNA leads to a breakthrough in clinical effectiveness of periodic surveillance for emerging or increase of ESR1 mutations in ctDNA, which could lead to a dramatic change from AI plus palbociclib to fullvestrant plus palbociclib treatment. Methods PADA-1 is a randomised, open-label, multicentric, phase III trial involving patients receiving AI and palbociclib as the first line therapy for metastatic ER+HER2- breast cancer patients. Patients will be tested for circulating blood ESR1 mutation detection at regular intervals. Patients for whom a growing circulating ESR1 mutation is present without tumor progression will be randomised between Arm A: no change in therapy; and Arm B: palbociclib, a selective ER down-regulator, and fulvestrant, a selective ER down-regulator.

Source link: https://europepmc.org/article/MED/35241469

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