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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

BCT 1901 (CAPTURE): Women or men with oestrogen receptor positive, HER2 negative advanced breast cancer and PIK3CA mutant circulating DNA will be randomised to evaluate treatment with alpelisib plus fulvestrant compared with capecitabine on progression free survival.

Excerpt:
...Advanced (locoregionally recurrent not amenable to curative therapy, or metastatic) ER-positive, HER2-negative breast cancer, histologically defined as:...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

Excerpt:
...To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who do not present a progressive disease after 6-8 cycles of chemotherapy.`...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Impact of time of alpelisib administration, concomitant fasting and low carbohydrate diet on alpelisib toxicity and efficacy; a pilot randomized controlled phase IIb trial - ITACA UTJECAJ VREMENA PRIMJENE ALPELISIBA, ISTOVREMENOG POSTA I PREHRANE S NISKIM UDJELOM UGLJIKOHIDRATA NA TOKSIČNOST I UČINKOVITOST ALPELISIBA; RANDOMIZIRANO I KONTROLIRANO PILOT ISPITIVANJE

Excerpt:
...Patient is an adult male or female (≥ 18 years of age) with advanced (loco regionally recurrent not amenable to curative therapy or metastatic) hormone receptor-positive, HER2-negative breast cancer2. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer

Excerpt:
...- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Excerpt:
...- Has confirmed HER2 negative breast cancer....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

Excerpt:
...- Histologically confirmed metastatic HR-positive, HER2-negative breast cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Excerpt:
...- Patient has confirmed HER2-negative advanced breast cancer (aBC)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Excerpt:
...- Postmenopausal females and males ≥ 18 years old with confirmed HR-positive, HER2-negative advanced or metastatic breast cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant

Excerpt:
...Participant with a confirmed HER2-negative ABC....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

Excerpt:
...Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseous, chondroid, and spindle morphology....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

Excerpt:
...Histologically confirmed metastatic HR-positive, HER2-negative breast cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

Excerpt:
...- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

Excerpt:
...- Clinical stage IV invasive mammary carcinoma, ER-positive and/or PR-positive by immunohistochemistry (IHC) and HER2 negative (by IHC or ISH)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer

Excerpt:
...HER2-negative breast cancer 2....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Excerpt:
...Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

Excerpt:
...Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry [IHC], for borderline2+ Fluorescence In Situ Hybridization [FISH]) 4....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

Excerpt:
...- Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

Excerpt:
...Histologically proven HER-2 negative breast cancer (HER-2 negative defined as HER IHC 0 or 1+ and/or HER-2 FISH negative); HER-2 negative breast cancer includes hormone positive (ER and/or PR positive) breast cancer and TNBC 4....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitor

Excerpt:
...- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Phase II exploratory, open-label, single arm study of BYL719 monotherapy, a selective PI3K alpha inhibitor, in adult patients with advanced breast cancer progressing after first line therapy

Excerpt:
...Patients with TNBC disease (ER<1%, HER2-negative) should have documented progression on at least one line of prior systemic therapy in the metastatic setting or within 12 months of adjuvant therapy completion. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical and biomarker results from phase I/II study of PI3K inhibitor BYL 719 (alpelisib) plus nab-paclitaxel in HER2-negative metastatic breast cancer.

Published date:
05/16/2016
Excerpt:
Alpelisib and nP combination shows encouraging efficacy with manageable toxicity in HER2 negative MBC. 
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.1200/JCO.2018.36.15_suppl.1018
Trial ID: