Clinical trial NCT04965688: Biology Guided Therapy for Breast Cancer for ER Positive
Official title: Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: City of Hope Medical Center
First posted: 2021-07-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, interventional
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Baseline to 36 Months
Secondary outcomes:
measure: Turn Around Time for Systems Biology Analysis
timeFrame: Baseline to 36 Months
measure: Response Rate to Systems Biology Guided Therapy
timeFrame: Baseline to 36 Months
measure: Progression Free Survival Base on Concordance With Recommended Treatment
timeFrame: Baseline to 36 Months
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: Inova Schar Cancer Institute
name: Adam Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: