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

Sponsor
Inova Health Care Services (Other)
Overall Status
Recruiting
CT.gov ID
NCT04965688
Collaborator
City of Hope Medical Center (Other)
74
Enrollment
1
Location
46.8
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug determined by treating oncologist based on recommendation from systems biology analysis.
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label, interventionalOpen label, interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
Actual Study Start Date :
Aug 8, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival [24 months]

Secondary Outcome Measures

  1. Turn around time for systems biology analysis [24 months]

  2. Response rate to systems biology guided therapy [24 months]

  3. Progression free survival base on concordance with recommended treatment [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inova Schar Cancer Institute Fairfax Virginia United States 22031

Sponsors and Collaborators

  • Inova Health Care Services
  • City of Hope Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT04965688
Other Study ID Numbers:
  • U21-02-4401
First Posted:
Jul 16, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Oct 14, 2021