Study assessing the efficacy and safety of alpelisib plus nab-paclitaxel in subjects with advanced triple negative breast cancer who carry either a PIK3CA mutation or have PTEN loss without PIK3CA mutatio

Phase 1

• Conditions: Advanced triple negative breast cancer; MedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002637-11-HR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-23
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

- Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC - Subject has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease - Subject has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B - PTEN loss without a PIK3CA mutation - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Subject has received no more than one line of therapy for metastatic disease. - Subject has adequate bone marrow and organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

Exclusion Criteria

- Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor - Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients - Subject has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade =1; with the exception of alopecia - Subject has central nervous system (CNS) involvement - Subject with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c - Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion - Subject has a history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis - Subject has currently documented pneumonitis/interstitial lung disease - Subject has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS) - Subject with unresolved osteonecrosis of the jaw Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified