Biology Guided Therapy for Breast Cancer for ER Positive

Last updated: April 8, 2025
Sponsor: Inova Health Care Services
Overall Status: Terminated

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Biopsy-Guided Therapy Selection

Drug determined by treating oncologist based on recommendation from systems biology analysis.

Clinical Study ID

NCT04965688
U21-02-4401
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 scleroticbone lesion

  • ECOG 0-2

  • Age 18 or greater

  • Able to provide informed consent and willing to sign an approved consent form thatconforms to federal and institutional guidelines.

Exclusion

Exclusion Criteria:

  • Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, orcapecitabine

  • Comorbid disease other than breast cancer with a life expectancy of less than 2years

  • Cancer other than breast cancer that is expected to need treatment within 2 years

  • Platelets < 100,000/microliter

  • INR > 1.5

Study Design

Total Participants: 2
Treatment Group(s): 2
Primary Treatment: Biopsy-Guided Therapy Selection
Phase: 2
Study Start date:
August 08, 2021
Estimated Completion Date:
March 13, 2024

Study 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.

Connect with a study center

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Site Not Available

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