Study Summary
This trial is testing whether a new drug is effective and safe for people with a certain type of breast cancer.
- HER2-positive Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: Up to approximately 70 months
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Part 2: Alpelisib + Trastuzumab + Pertuzumab
1 of 3
Part 1: Alpelisib + Trastuzumab + Pertuzumab
1 of 3
Part 2: Alpelisib matching Placebo + Trastuzumab + Pertuzumab
1 of 3
Experimental Treatment
Non-Treatment Group
19 Total Participants · 3 Treatment Groups
Primary Treatment: Alpelisib · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What are the conditions that Alpelisib is indicated to treat?
"Alpelisib is often used in the treatment of breast cancer, but it has also been shown to be effective against high risk of recurrence and first line treatment." - Anonymous Online Contributor
To what extent has Alpelisib been studied in the past?
"Alpelisib was first studied two decades ago at Ospedale di Circolo e Fondazione Macchi. There have been 397 completed trials of the medication since then. As of now, there are 236 clinical trials underway that are recruiting patients. Many of these studies are being conducted out of Kingwood, New York." - Anonymous Online Contributor
Is Alpelisib a safe medication for patients to take?
"We have given Alpelisib a score of 3 for safety. This is because it is a Phase 3 trial, which means that there is both some evidence of its efficacy and multiple rounds of data supporting its safety." - Anonymous Online Contributor
Are people currently being accepted into this experiment?
"This clinical trial, as listed on clinicaltrials.gov, is seeking patients at this time. The trial was first posted on 7/16/2020 and was last updated on 10/21/2022." - Anonymous Online Contributor
What are the overarching goals of this research?
"The sponsor of this clinical trial, Novartis Pharmaceuticals, reports that the primary outcome being measured over a six-week period is progression-free survival (PFS). Additionally, this trial will observe secondary outcomes such as PFS based on local radiology assessments, clinical benefit rate (CBR) with confirmed response, and alpelisib concentrations by timepoint and dose level." - Anonymous Online Contributor