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

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subject is ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
2.Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC. This diagnosis should be established from the most recently analyzed biopsy from a metastatic or locally recurrent site (local lab) and meet the following criteria:
a. HER2 negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0 or 1+, and
b. ER and PR expression is <1 percent as determined by IHC (Hammond et al 2010).
Note: Subjects that were previously identified with ER-positive, or PR-positive or HER2-positive early disease are allowed into the study if they have confirmed TNBC (meeting criteria 2a and 2b) by tumor biopsy in the locally advanced or metastatic setting at the time of screening
3.Subject has either:
a.Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR
b.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 Computerized Tomography (CT) /Magnetic Resonance Imaging (MRI)) must be present
4.Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1.Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor.
2.Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients.
3.Subject with inflammatory breast cancer.
4.Subject is concurrently using other anti-cancer therapy.
5.Subject has had surgery within 14 days prior to starting study drug or has not recovered from major side effects.
6.Subject has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: subjects with any grade of alopecia are allowed to enter the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:PFS will be assessed via a local radiology assessment according to RECIST 1.1.<br>ORR- local radiology assessments<br>Measure:PFS - Progression Free Survival<br>ORR - Overall Response Rate<br>Timepoints:PFS - defined as the time from the date of randomization to the date of the first documented progression or death due to any cause<br>ORR with confirmed response at 6 months, based on local radiology assessments in subjects with measurable disease at baseline<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:ECOG performance status, and safety.<br>Measure:overall response rate (ORR), clinical benefit rate (CBR), time to response (TTR), duration of response (DOR)<br><br>PFS, overall survival (OS),<br>Timepoints:time to definitive deterioration in quality of life, time to definitive deterioration<br>

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