A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment with Inavolisib Combinations in Patients with Untreated, Early-Stage, PIK3CA-Mutated Breast Cancer

Early-Stage, PIK3CA-Mutated Breast Cancer (BC)

Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading scale, Change from baseline in selected clinical laboratory test results, Tolerability, as assessed by the overall treatment exposure and the incidence of dose modifications

Pathologic Complete Response (pCR) rate in breast and axilla (ypT0/Tis ypN0) according to local pathologist assessment following the American Joint Committee on Cancer (AJCC) TNM staging system (Amin et al. 2017; NCCN 2024), Tumor overall objective response rate (ORR), Changes in Ki-67 by immunohistochemistry (IHC), Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed through use of the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE), Proportion of participants reporting each response option at each assessment timepoint for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General (FACT-G), Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of PRO-CTCAE and the FACT-G GP5 item

No related papers found yet.

Germany, Spain