Trials / Completed
CompletedNCT05101564
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Jennifer Lee Caswell-Jin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy in in reducing Ki67 values based on digital pathology (QuPath) from baseline to on-treatment biopsy after an specific treatment duration (i.e. 14 days) in ER-positive, HER2-negative tumors (tumor size ≥1 cm) with Ki67 ≥ 10%, for different integrative subtype categories identified at integrative subtype screening. Secondary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy on the proportion of subjects with Ki67 \< 10% after a specific treatment duration (i.e. 14 days)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alpelisib | Alpelisib 300 mg |
| DRUG | Tamoxifen | Tamoxifen 20 mg |
| DRUG | Zotatifin | Zotatifin 0.10mg/kg (by weight) |
| DRUG | Fulvestrant | Fulvestrant 500 mg |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2024-06-03
- Completion
- 2024-06-03
- First posted
- 2021-11-01
- Last updated
- 2026-02-12
- Results posted
- 2026-01-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05101564. Inclusion in this directory is not an endorsement.