Biology Guided Therapy for Breast Cancer for ER Positive

NCT04965688 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: U21-02-4401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.

Conditions

Breast Cancer; Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  No data displayed because Outcome Measure has zero total participants analyzed.

  Baseline to 36 Months

Secondary Outcomes (3)

• Turn Around Time for Systems Biology Analysis

  Baseline to 36 Months

• Response Rate to Systems Biology Guided Therapy

  Baseline to 36 Months

• Progression Free Survival Base on Concordance With Recommended Treatment

  Baseline to 36 Months

Study Arms (1)

Personalized Cancer Treatment Based on Biopsy Results

OTHER

Drug: Biopsy-Guided Therapy Selection

Interventions

Biopsy-Guided Therapy Selection DRUG

All enrolled participants will undergo a tumor biopsy, which will be analyzed for genomic and transcriptomic alterations using FoundationOne (DNA) and Fulgent (RNA). Based on the genomic findings, participants will receive one of the following therapy standard-of-care treatment options: PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant) MTOR inhibitor + anti-estrogen therapy (everolimus + exemestane) Anti-estrogen therapy alone (fulvestrant monotherapy) Cytotoxic chemotherapy (capecitabine)

Personalized Cancer Treatment Based on Biopsy Results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of breast cancer
• Metastatic or incurable
• Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor
• Progression while on or within 6 months of stopping the CDK4/6 inhibitor
• At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion
• ECOG 0-2
• Age 18 or greater
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

You may not qualify if:

• Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine
• Comorbid disease other than breast cancer with a life expectancy of less than 2 years
• Cancer other than breast cancer that is expected to need treatment within 2 years
• Platelets \< 100,000/microliter
• INR \> 1.5

Sponsors & Collaborators

• Inova Health Care Services: lead
• City of Hope Medical Center: collaborator

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Adam Cohen, MD
• Organization: Inova Health System

adam.cohen@inova.org

7035767279

Study Officials

• Adam Cohen, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, interventional

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: August 8, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)