CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Alpelisib +3 moredrug
Likely dose
Alpelisib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05101564
NCT05101564Phase 2Completed
CompareCT.gov

An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer

Jennifer Lee Caswell-Jin·interventional·Posted Nov 1, 2021·Updated Feb 12, 2026

In Brief

A Phase 2 clinical trial evaluating Alpelisib, Tamoxifen, and 2 other interventions for Breast Cancer and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense, Novartis Pharmaceuticals, Effector Therapeutics

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedNov 1, 2021
Enrollment StartMar 20, 2023
Primary CompletionJun 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.7 years ago

Interventions

Alpelisibdrug

Alpelisib 300 mg

Tamoxifendrug

Tamoxifen 20 mg

Zotatifindrug

Zotatifin 0.10mg/kg (by weight)

Fulvestrantdrug

Fulvestrant 500 mg