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Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

NCT05101564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-02-12

Study results available
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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.

Conditions

Interventions

DRUG

Alpelisib

Alpelisib 300 mg

DRUG

Tamoxifen

Tamoxifen 20 mg

DRUG

Zotatifin

Zotatifin 0.10mg/kg (by weight)

DRUG

Fulvestrant

Fulvestrant 500 mg

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Effector Therapeutics

    collaborator INDUSTRY

  • Jennifer Lee Caswell-Jin

    lead OTHER

Principal Investigators

  • Jennifer Caswell-Jin · Stanford Universiy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-06-03
Completion
2024-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05101564 on ClinicalTrials.gov