Clinical trial NCT04965688
Conditions: Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer
Sponsor: Inova Health Care Services
Start date: 2021-08-08; Completion date: 2024-03-13
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Detailed description:
This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.

Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.

Arms: arm 1: None
Interventions: intervention 1: Biopsy-Guided Therapy Selection
Intervention descriptions: intervention 1: All enrolled participants will undergo a tumor biopsy, which will be analyzed for genomic and transcriptomic alterations using FoundationOne (DNA) and Fulgent (RNA). Based on the genomic findings, participants will receive one of the following therapy standard-of-care treatment options:

PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant)

MTOR inhibitor + anti-estrogen therapy (everolimus + exemestane)

Anti-estrogen therapy alone (fulvestrant monotherapy)

Cytotoxic chemotherapy (capecitabine)

Protocol documents:
Prot_SAP_ICF_001.pdf: 
 
Inova.org 
 
 
 
Cover Page 
 
 
 
 
 
Principal Investigator: 
Adam Cohen, MD 
 
Protocol Title: 
Biology Guided Therapy for Breast Cancer Positive for Oestrogen 
Receptor after Aromatase Inhibitor and CDK inhibition (SPOCK) 
 
NCT Number:  
 
NCT04965688 
 
Protocol Version Date: 
August 08, 2022 
 
IRB approval Date:   
September 18, 2022 
 
Protocol Number:  
 
U21-02-4401, WCG IRB Protocol #20212138 
Inova Schar Cancer  
Clinical Trials Office 
8081 Innovation Park Drive 
Fairfax, VA 22031 


 
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