Systems Biology Guided Therapy for Breast Cancer
(SPOCK Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAdam Cohen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Inova Health Care Services

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adam Cohen, MD

Principal Investigator

Inova Schar Cancer Institute

Eligibility Criteria

This trial is for adults with metastatic breast cancer that's positive for estrogen receptor and has worsened after treatment with aromatase inhibitors and CDK4/6 inhibitors. Participants need to have a tumor suitable for biopsy, be in fairly good health (ECOG 0-2), and not have received certain other treatments or have another life-threatening cancer.

Inclusion Criteria

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

I have been diagnosed with breast cancer.

I have been treated with anastrozole or letrozole and a CDK4/6 inhibitor.

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Exclusion Criteria

I have not taken fulvestrant, alpelisib, everolimus, or capecitabine in the last 2 years.

Your blood platelet count is less than 100,000 per microliter.

I have a health condition besides breast cancer that may shorten my life to under 2 years.

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Treatment Details

Interventions

Aromatase Inhibitor (Hormone Therapy)
CDK Inhibition (CDK4/6 Inhibitor)

Trial OverviewThe study aims to see if using the biology of tumors can predict which among several approved treatments would work best for individuals whose breast cancer has progressed on specific previous therapies. It also seeks to gather more information about these tumors to develop better future treatments.