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Hormone Therapy

Systems Biology Guided Therapy for Breast Cancer (SPOCK Trial)

Phase 2

Recruiting

Led By Adam Cohen, MD

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic diagnosis of breast cancer

Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

SPOCK Trial Summary

This trial is testing if scientists can correctly predict which of several guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer is best for each patient, using the tumor's biology.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

While the summary doesn't specify side effects, typical ones from such therapies may include fatigue, nausea, skin reactions, low blood counts leading to increased infection risk or bleeding problems, hormonal changes, and potential liver issues.

SPOCK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with breast cancer.

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

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am 18 years old or older.

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I have a tumor that can be biopsied without surgery.

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My condition is incurable and has spread to other parts of my body.

SPOCK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Progression free survival base on concordance with recommended treatment

Response rate to systems biology guided therapy

Turn around time for systems biology analysis

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor

69 Previous Clinical Trials

22,181 Total Patients Enrolled

3 Trials studying Breast Cancer

87 Patients Enrolled for Breast Cancer

City of Hope Medical CenterOTHER

567 Previous Clinical Trials

1,922,586 Total Patients Enrolled

42 Trials studying Breast Cancer

6,575 Patients Enrolled for Breast Cancer

Adam Cohen, MDPrincipal InvestigatorInova Schar Cancer Institute

6 Previous Clinical Trials

167 Total Patients Enrolled

Media Library

Aromatase Inhibitor (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04965688 — Phase 2

Breast Cancer Clinical Trial 2023: Aromatase Inhibitor Highlights & Side Effects. Trial Name: NCT04965688 — Phase 2

Aromatase Inhibitor (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965688 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this therapy pose any risk to those who use it?

"The safety of this treatment has been provisionally rated at 2. This is because, even though there is evidence to suggest the procedure does not pose a risk to its participants, no studies have yet proven that it is effective."

Answered by AI

To what extent is the sample size of this experiment?

"Yes, this clinical trial is actively seeking participants. According to the details posted on clinicaltrials.gov, recruitment began August 8th 2021 and was last updated October 26th 2022. The study requires 74 individuals to be recruited from one site."

Answered by AI

Are there still vacancies available for this trial's participants?

"According to clinicaltrials.gov, this research is actively seeking candidates with the initial posting of August 8th 2021 and last updated on October 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965688.