Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

  • STATUS
    Recruiting
  • End date
    Jan 9, 2026
  • participants needed
    566
  • sponsor
    Novartis Pharmaceuticals
Updated on 14 July 2021
paclitaxel
cancer
measurable disease
breast cancer
metastasis
PIK3CA
PTEN
mammogram

Summary

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Triple Negative Breast Neoplasms, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Placebo, Nab-paclitaxel, Alpelisib
Clinical Study IdentifierNCT04251533
SponsorNovartis Pharmaceuticals
Last Modified on14 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC
Participant 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
Participant 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 B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant has received no more than one line of therapy for metastatic disease
Participant has adequate bone marrow and organ function

Exclusion Criteria

Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade 1; with the exception of alopecia
Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening
Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
Participant 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
Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
Participant has currently documented pneumonitis/interstitial lung disease
Participant 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)
Participant with unresolved osteonecrosis of the jaw
Other protocol-defined inclusion/exclusion criteria apply
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