Clinical Trials Logo

Clinical Trial Summary

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.


Clinical Trial Description

This is an international, multicenter, open-label, controlled phase III randomized clinical trial in HER2+ advanced breast cancer (ABC) patients harboring PIK3CA mutation. Approximately 300 patients (144 in the HR- cohort and 156 in the HR+ cohort) will be enrolled. Central screening of PIK3CA mutations on the most recent available formalin-fixed paraffinembedded (FFPE) tumor sample is required for the purpose of eligibility. Investigators will be encouraged to send the most recent tumor tissue, preferably from a metastatic lesion. However, if this is not possible, archived tissue samples either from primary tumor or metastatic lesion will be acceptable. Local screening of HR and HER2 status is required (although there will be a central confirmation done retrospectively). Once the screening process (locally at each site and at the central laboratory) is completed, fully eligible patients will be randomized in a 1:1 fashion to the control arm with trastuzumab plus chemotherapy (CT) or to the experimental arm with trastuzumab + alpelisib +/- fulvestrant (depending on HR status). The two patient cohorts defined according to HR status will be randomized separately, with randomization in each cohort stratified by prior treatment with pertuzumab (yes vs no) and number of prior anti-HER2 based therapy lines for MBC (≤2 vs >2). In both cohorts patients will continue to receive their assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. After objective disease progression, patients in both treatment arms will be followed until death or withdrawal of consent. In order to perform exploratory biomarker analysis, pre-treatment tumor and sequential blood samples (at baseline, at week 9, at the end of treatment [EOT], and at progressive disease [PD]) will be obtained. Additionally, blood samples from approximately 100 patients (50 HR+ and 50 HR-) screened and without PIK3CA mutation will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063786
Study type Interventional
Source Spanish Breast Cancer Research Group
Contact Study Project Manager
Phone +34916592870
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 2021
Completion date July 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04653740 - Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer N/A
Not yet recruiting NCT04756765 - Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Phase 2
Completed NCT00754325 - Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor Phase 2
Completed NCT03240224 - Bioinformation Therapy for Breast Cancer Phase 2/Phase 3
Not yet recruiting NCT04953377 - PFMT Educational Intervention for Patients With Advancer Breast Cancer N/A
Not yet recruiting NCT04862143 - 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 Phase 2
Active, not recruiting NCT03312738 - A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor Phase 2
Recruiting NCT03205761 - Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer Phase 2
Active, not recruiting NCT02499146 - Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer Phase 1
Completed NCT00445458 - A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer Phase 1/Phase 2
Recruiting NCT04456855 - Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Recruiting NCT04408118 - First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Not yet recruiting NCT04942054 - A Study in Patients With Advanced Breast Cancer Phase 1
Completed NCT00546104 - Phase II Dasatinib Study in Advanced Breast Cancer Phase 2
Completed NCT00387907 - Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer Phase 2
Recruiting NCT03685331 - HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer Phase 1
Completed NCT02952729 - Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2 Phase 1
Not yet recruiting NCT05077449 - A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer Phase 3
Completed NCT00327769 - Faslodex Advanced Breast Cancer Local Chinese Study Phase 3