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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Piqray (alpelisib) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Long-term (LT) disease control in patients (pts) with hormone receptor-positive (HR+), PIK3CA-altered advanced breast cancer (ABC) treated with alpelisib (ALP) + fulvestrant (FUL).
Published date:
05/19/2021
Excerpt:
... study of ALP (or placebo) + FUL in HR+, HER2– ABC...169 pts (30.2%) randomized to ALP + FUL achieved LT disease control with a median PFS of 33.5 mo…
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2021.39.15_suppl.1054
Trial ID:
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:
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:
More C2 evidence
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:
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:
SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer
Excerpt:
...Hormone receptor positive (HR+) and...
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:
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:
Less C2 evidence
Source:
Title:
The efficacy and safety of alpelisib in breast cancer: A real-world analysis
Published date:
04/22/2022
Excerpt:
CONTRADICTING EVIDENCE: Forty-nine percent of patients discontinued alpelisib + fulvestrant due to progression of disease...This analysis demonstrates that the outcomes of alpelisib + fulvestrant were worse in the real-world salvage setting in HR+, HER2- metastatic breast cancer as compared to the front-line setting….
Secondary therapy:
fulvestrant
DOI:
https://doi.org/10.1177/10781552221096413
Source:
Title:
Alpelisib monotherapy for PI3K-altered, pre-treated advanced breast cancer: A phase II study
Published date:
10/09/2021
Excerpt:
Alpelisib monotherapy in pre treated ER+HER2- disease showed evidence of clinical efficacy.
Source:
Title:
A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer
Published date:
01/15/2021
Excerpt:
This study enrolled premenopausal women with HR+, HER2- ABC. Patients received tamoxifen (20 mg once daily) and goserelin acetate (3.6 mg every 28 days) with either alpelisib (350 mg once daily; n = 16) or buparlisib (100 mg once daily; n = 13)...Progression-free survival was 25.2 months in the alpelisib group and 20.6 months in the buparlisib group.
Secondary therapy:
tamoxifen + goserelin acetate
DOI:
10.1158/1078-0432.CCR-20-1008
Trial ID:
Source:
Title:
BYLieve: A phase II study of alpelisib (ALP) with fulvestrant (FUL) or letrozole (LET) for treatment of PIK3CA mutant, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (aBC) progressing on/after cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy.
Published date:
05/20/2020
Excerpt:
127 pts whose immediate prior tx was CDKi + AI were enrolled, of whom 121 had centrally confirmed PIK3CA mut; median follow-up was 11.7 mo. Primary endpoint was met...BYLieve shows in a large number of pts that ALP + FUL demonstrates clinically meaningful efficacy and manageable toxicity post CDKi tx.
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2020.38.15_suppl.1006
Trial ID:
