Biology Guided Therapy for Breast Cancer for ER Positive

NCT ID: NCT04965688

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-08
• Study Completion Date: 2024-03-13

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.

Detailed Description

This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.

Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized Cancer Treatment Based on Biopsy Results

Group Type: OTHER

Biopsy-Guided Therapy Selection

Intervention Type: 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)

Interventions

Biopsy-Guided Therapy Selection

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City of Hope Medical Center

OTHER

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Schar Cancer Institute

Locations

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

U21-02-4401

Identifier Type: -

Identifier Source: org_study_id