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Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition

Recruiting
18 years of age
Both
Phase 2

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Overview

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

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 details

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

NCT04965688

Inova Health Care Services

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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