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 Without PIK3CA Mutation

STATUS

Recruiting
End date

Jan 9, 2026
participants needed

566
sponsor

Novartis Pharmaceuticals

Send

Updated on 19 February 2024

See if I qualify

cancer

breast cancer

measurable disease

metastasis

paclitaxel

triple negative breast cancer

alpelisib

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 without PIK3CA mutation (Study Parts B1 and B2)

Details

Condition	Breast Cancer, Breast Cancer, Breast Cancer - HER2 Positive
Age	18-100 years
Treatment	Placebo, nab-paclitaxel, Alpelisib
Clinical Study Identifier	NCT04251533
Sponsor	Novartis Pharmaceuticals
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
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

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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 Without PIK3CA Mutation