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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Piqray (alpelisib) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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+. ...
Trial ID:
Source:
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:
More C2 evidence
Source:
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. ...
Trial ID:
Source:
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:
Source:
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:
Source:
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....
Trial ID:
Source:
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:
Source:
Title:
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
Excerpt:
......
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer
Excerpt:
...HER2-negative breast cancer 2....
Trial ID:
Source:
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:
Source:
Title:
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
Excerpt:
......
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
Excerpt:
......
Trial ID:
Source:
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:
Source:
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. ...
Trial ID:
Source:
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:...
Trial ID:
Less C2 evidence
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:
