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

Breast Cancer Clinical Trial

— SPOCK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965688
• Other study ID #: U21-02-4401
• Status: Recruiting
• Phase: Phase 2
• Start date: August 8, 2021
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Inova Health Care Services
• Contact: Stephanie Van Bebber, MSc.
• Phone: 571-472-0213
• Email: Stephanie.VanBebber[@]inova.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Receptor-positive Breast Cancer
• HER2-negative Breast Cancer

Intervention

Drug:
• Drug determined by treating oncologist based on recommendation from systems biology analysis.
All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		24 months
Secondary	Turn around time for systems biology analysis		24 months
Secondary	Response rate to systems biology guided therapy		24 months
Secondary	Progression free survival base on concordance with recommended treatment		24 months