Biology Guided Therapy for Breast Cancer for ER Positive (SPOCK)

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer
• Intervention / Treatment: Drug: Biopsy-Guided Therapy Selection

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Personalized Cancer Treatment Based on Biopsy Results

Drug: Biopsy-Guided Therapy Selection; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	No data displayed because Outcome Measure has zero total participants analyzed.	Baseline to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turn Around Time for Systems Biology Analysis	No data displayed because Outcome Measure has zero total participants analyzed.	Baseline to 36 Months
Response Rate to Systems Biology Guided Therapy	No data displayed because Outcome Measure has zero total participants analyzed.	Baseline to 36 Months
Progression Free Survival Base on Concordance With Recommended Treatment	No data displayed because Outcome Measure has zero total participants analyzed.	Baseline to 36 Months

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: City of Hope Medical Center
• Investigators: Principal Investigator: Adam Cohen, MD, Inova Schar Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: U21-02-4401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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