Biology Guided Therapy for Breast Cancer for ER Positive

Phase 2

Terminated

• Conditions: HER2-negative Breast Cancer; Breast Cancer; Estrogen Receptor-positive Breast Cancer
• Interventions: Drug: Biopsy-Guided Therapy Selection

• Registration Number: NCT04965688
• Lead Sponsor: Inova Health Care Services

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Study Start: 2021-08-08
• Primary Completion: 2024-03-13
• Study Completion: 2024-03-13
• Results First Submitted: 2025-02-28
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Results First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized Cancer Treatment Based on Biopsy Results	Biopsy-Guided Therapy Selection	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Baseline to 36 Months	No data displayed because Outcome Measure has zero total participants analyzed.

Secondary Outcome Measures

Name	Time	Method
Turn Around Time for Systems Biology Analysis	Baseline to 36 Months	No data displayed because Outcome Measure has zero total participants analyzed.
Response Rate to Systems Biology Guided Therapy	Baseline to 36 Months	No data displayed because Outcome Measure has zero total participants analyzed.
Progression Free Survival Base on Concordance With Recommended Treatment	Baseline to 36 Months	No data displayed because Outcome Measure has zero total participants analyzed.

Trial Locations

Locations (1)

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States