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Brief Title: PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin
Official Title: Phase II Study for PIK3CA/PTEN-altered Advanced Metaplastic Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin
Study ID: NCT05810870
Brief Summary: The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in Hormone Receptor (HR)-known/Human Epidermial Growth Factor Receptor 2 (HER2)-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/ Phosphatase and Tensin Homolog (PTEN)-altered, unresectable locally advanced or metastatic metaplastic breast carcinoma (MpBC) patients. A run-in phase for safety and tolerability of MEN1611 in combination with standard doses of eribulin will be conducted as an initial step of the cohort A. This first step aims at evaluating the dosing schedule of MEN1611, by analyzing the toxicity profile of the combined regimen. With the background of the first-in-human study (PA-001EU), the safe dose of MEN1611 has been established as 48 mg orally BID (two intakes of 3 capsules of 16 mg each, for a total daily dose of 96 mg MEN1611 free-base).
Detailed Description: This is a multicenter, two-cohort, non-comparative, open-label, phase II clinical trial to assess: * the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR) in unresectable locally advanced or metastatic HR-known/HER2-negative, PIK3CA/ PTEN-altered MpBC patients (Cohort A), and * the efficacy of MEN1611 as monotherapy as determined by the objective response rate (ORR) at 6 weeks in unresectable locally advanced or metastatic HR-known/HER2-negative, PIK3CA/ PTEN-altered MpBC patients (Cohort B). Upon meeting all selection criteria, 28 patients will be enrolled as follows: - Cohort A: A run-in phase for safety and tolerability of MEN1611 in combination with eribulin will be conducted in this patient population (N=3). A Steering Committee decision/agreement is needed, after reviewing all toxicities, to expand this cohort with 11 additional patients (up to N=14). Cohort B will be run only if positive finding in Cohort A, defined as ≥ 6 patients (42.9%) with achieved clinical benefit (CB) among 14 first recruited patients. - Cohort B: Simon's two-stage minimax design. Stage I (N=7) will be initiated with MEN1611 monotherapy. This cohort will be stopped for futility if no responders (no complete response \[CR\] or partial response \[PR\]) are observed after 2 cycles among the first 7 patients included. Otherwise, Cohort B will be expanded with 7 additional patients for Stage II (up to N=14).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario Clínico San Cecilio de Granada, Granada, Andalucia, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Andalucia, Spain
Hospital Universitario de Torrejón, Torrejón De Ardoz, Madrid, Spain
Onkologikoa, San Sebastián, Pais Vasco, Spain
CHUVI - Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain
Institut Català d' Oncologia L'Hospitalet (ICO), Barcelona, , Spain
Vall d'Hebron, Barcelona, , Spain
Instituto Valenciano de Oncología (IVO), Valencia, , Spain
Name: José Pérez, MD
Affiliation: Institute of Breast Cancer, Quirón Group, Barcelona (Spain)
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Llombart-Cussac, MD
Affiliation: Arnau de Vilanova Hospital, Valencia (Spain)
Role: PRINCIPAL_INVESTIGATOR