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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Piqray (alpelisib) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Which Is the Most Appropriate PI3K Inhibitor for Breast Cancer Patients with or without PIK3CA Status Mutant? A Systematic Review and Network Meta-Analysis
Published date:
12/03/2020
Excerpt:
Nine eligible RCTs involving 3872 BC patients and four PI3K inhibitor therapy arms (i.e., alpelisib, buparlisib, pictilisib, and taselisib) were included....The PI3K inhibitors alpelisib and buparlisib appear to have superior efficacy and safety therapeutic choices for patients with BC, especially in PIK3CA-mutated patients.
DOI:
10.1155/2020/7451576
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:
...- Participants with confirmed PIK3CA mutant advanced or metastatic breast cancer...
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:
...- Participant must show the presence of a PIK3CA mutation(s) determined in tumor tissue prior ro enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test....
Trial ID:
More C2 evidence
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 pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood)....
Trial ID:
Source:
Title:
A Post Marketing Surveillance on Piqray in Korea
Excerpt:
...Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer....
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:
...- Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation...
Trial ID:
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:
...- The presence of a PIK3CA mutation(s) determined by tissue either by a local laboratory using only CE-marked IVD assays such as QIAGEN Therascreen® PIK3CA RGQ PCR test or by a Novartis designated laboratory. ...
Trial ID:
Source:
Title:
SEQUEL-Breast: a phase 2 study on the combination of alpelisib and fulvestrant after progression on previous therapy with fulvestrant in patients with PIK3CA-mutated, hormone-receptor positive, HER2 negative advanced breast cancer De SEQUEL-studie: een studie naar het gebruik van alpelisib en fulvestrant bij patiënten met hormoongevoelige PIK3CA-gemuteerde uitgezaaide borstkanker, die al eerder met fulvestrant behandeld zijn.
Excerpt:
...The presence of an activating PIK3CA mutation.6. ...
Trial ID:
Source:
Title:
Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer
Excerpt:
...PIK3CA mutation in tumor tissue or ctDNA as determined by a local laboratory 5....
Trial ID:
Source:
Title:
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
Excerpt:
...- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant)...
Trial ID:
Source:
Title:
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
Excerpt:
...Phase lb only`Dose Limiting Toxicities (DLTs) - Phase Ib`The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. ...
Trial ID:
Source:
Title:
A phase II randomized trial comparing alpelisib and fulvestrant versus chemotherapy as maintenance therapy in patients with PIK3CA mutated advanced breast cancer
Excerpt:
...Presence of PIK3CA mutation on exon 9 or 20, determined on metastatic tissue specimen (frozen or FFPE) or plasma (ctDNA). ...
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 are defined as “PI3K abnormal” if they have documented gene mutation in AKT1,2,3,ALK, EGFR, ERBB2,3,4, HRAS, INPP4B, KRAS, NRAS, PTEN, PIK3CA, PIK3R1, PIK3R3, PTEN or gene amplification in EGFR, PIK3CA, PIK3R1 or loss in PTEN and INPP4B as per a next generation targeted gene sequencing panel...
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:
...PIK3CA mutation (PIK3CA E542K, E545K, H1047L or H1047R mutation) identified through ctDNA testing....
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 has documented evidence of a mutation in the PIK3CA gene as determined in tumor tissue or plasma by a local laboratory.3. ...
Trial ID:
Source:
Title:
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
Excerpt:
...- Presence of one or more activating PIK3CA mutations in tumor tissue....
Trial ID:
Source:
Title:
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
Excerpt:
...- Activating mutations in PIK3CA (cohort-1), or loss of function alterations in PTEN by next generation sequencing (NGS) or IHC (cohort-2) (based on MD Anderson Cancer Center [MDACC] Dako 6H2.1 assay)...
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 a PIK3CA mutation confirmed by Novartis designated central lab or patient has a pathology report confirming PIK3CA mutant status by certified laboratory (using validated PI3KCA mutation assay) either from tissue or blood and must (mandatory) send tumor tissue to Novartis designated central lab for confirmation of mutational status -...
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 adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory....
Trial ID:
Source:
Title:
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
Excerpt:
...- Participant 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...
Trial ID:
Source:
Title:
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
Excerpt:
...- Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory....
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:
...- PIK3CA mutation identified via local testing from tumor tissue or blood....
Trial ID:
Source:
Title:
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
Excerpt:
...Presence of one or more activating PIK3CA mutations in tumor tissue....
Trial ID:
Source:
Title:
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
Excerpt:
...- Participant has a PIK3CA mutation(s) present in tumor prior to enrollment...
Trial ID:
Source:
Title:
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
Excerpt:
...- A minimum of 10 patients in the trial (~50%) will need to have a PIK3CA mutation in their 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 adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory....
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:
...Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort...
Trial ID:
Source:
Title:
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer
Excerpt:
...Patient has documented evidence of a mutation in the PIK3CA gene as determined in tumor tissue or plasma by a local laboratory....
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:
...- The presence of an activating PIK3CA mutation...
Trial ID:
Source:
Title:
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
Excerpt:
...Participants with confirmed positive PIK3CA mutation status prior to study entry....
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:
...Presence of PIK3CA mutation on exon 9 or 20, determined on metastatic tissue specimen (frozen or FFPE) or plasma (ctDNA)....
Trial ID:
Source:
Title:
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
Excerpt:
...- Patients are defined as "PI3K abnormal" if they have documented gene mutation in AKT1,2,3,ALK, EGFR, ERBB2,3,4, HRAS, INPP4B, KRAS, NRAS, PTEN, PIK3CA, PIK3R1, PIK3R3, PTEN or gene amplification in EGFR, PIK3CA, PIK3R1 or loss in PTEN and INPP4B as per a next generation targeted gene sequencing panel...
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and Safety of Alpelisib in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor: An Open-label, Multi-centre, Prospective, Single Arm Clinical Trial
Published date:
12/02/2023
Excerpt:
Our trial demonstrates activity of alpelisib in patients with PIK3CA mutated advanced breast cancer in later lines of treatment after treatment with CDK4/6 inhibitors with a clinical benefit rate of 26.3%.
Source:
Title:
Phase Ib and pharmacokinetics study of alpelisib, a PIK3CA inhibitor, and capecitabine in patients with advanced solid tumors
Published date:
07/18/2023
Excerpt:
Patients with 6 colorectal cancer (three PIK3CA mutation) and 6 breast cancer (all PIK3CA mutation) were enrolled. The first three patients in dose level 0 (alpelisib 200mg, capecitabine 1,000 mg/m2)...Antitumor activity was observed in patients with PIK3CA mutant breast cancer (3 partial response and 3 stable disease)....This combination is generally tolerated, and shows antitumor activity in patients with PIK3CA mutant advanced cancers.
Secondary therapy:
capecitabine
DOI:
https://doi.org/10.21203/rs.3.rs-3174557/v1
Source:
Title:
Likelihood of benefit from large panel genetic profiling in a community hospital system
Published date:
05/19/2021
Excerpt:
With the addition of targeted agents, 4 patients (3.9%) displayed clinical benefit. Two of these patients had gastric and endometrial carcinoma with high TMB and were placed on immunotherapy. They experienced 638 and 465 days, respectively, of stable disease with partial response. Another breast cancer patient had a PIK3CA mutation with PFS of 131 days on alpelisib.
DOI:
10.1200/JCO.2021.39.15_suppl.e15025
Source:
Title:
Alpelisib to treat breast cancer
Published date:
06/01/2020
Excerpt:
The combination of alpelisib with fulvestrant or an aromatase inhibitor such as letrozole is safe and effective with reversible toxicities. Although clinical activity has been observed independently of PIK3CA mutation status, clinical improvement has been mostly seen in a higher proportion of patients with PIK3CA-mutated tumors. In this review I share current data on alpelisib in breast cancer treatment.
Secondary therapy:
fulvestrant; letrozole
DOI:
10.1358/dot.2020.56.6.3137526
Source:
Title:
3447 - NOS inhibition reverses epithelial-to-mesenchymal transition and synergizes with alpelisib in metaplastic breast cancer
Published date:
03/15/2023
Excerpt:
L-NMMA was synergistic with alpelisib in MpBC cell lines with PIK3CA/PIK3R1 mutations…. In vivo evaluation using MpBC PDX tumors found that L-NMMA augmented the efficacy of alpelisib in reducing tumor volume in PIK3CA-mutated MpBC PDX models….We find that combining L-NMMA and alpelisib is a novel therapeutic strategy to treat MpBC...
Secondary therapy:
L-NMMA
Source:
Title:
NOS inhibition reverses epithelial-to-mesenchymal transition and synergizes with alpelisib in metaplastic breast cancer
Published date:
11/22/2022
Excerpt:
Combining L-NMMA with alpelisib was synergistic in MpBC cell lines harboring PIK3CA/PIK3R1 mutations (CI< 1)….In vivo evaluation using MpBC PDX tumors found that L-NMMA significantly augmented the efficacy of alpelisib in reducing tumor volume in PIK3CA-mutated MpBC PDX models.
Secondary therapy:
L-NMMA
