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

Primary Purpose

Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug determined by treating oncologist based on recommendation from systems biology analysis.
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inova Schar Cancer InstituteRecruiting

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Turn around time for systems biology analysis
Response rate to systems biology guided therapy
Progression free survival base on concordance with recommended treatment

Full Information

First Posted
July 7, 2021
Last Updated
September 1, 2023
Sponsor
Inova Health Care Services
Collaborators
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04965688
Brief Title
Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
Acronym
SPOCK
Official Title
Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
Collaborators
City of Hope Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label, interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Drug determined by treating oncologist based on recommendation from systems biology analysis.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Turn around time for systems biology analysis
Time Frame
24 months
Title
Response rate to systems biology guided therapy
Time Frame
24 months
Title
Progression free survival base on concordance with recommended treatment
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Van Bebber, MSc.
Phone
571-472-0213
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
Keary Janet, BS
Phone
571-472-0224
Email
keary.janet@inova.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Cohen, MD
Organizational Affiliation
Inova Schar Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Van Bebber, MSc.
Phone
571-472-0213
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Keary Janet, BS
Phone
571-471-0224
Email
keary.janet@inova.org
First Name & Middle Initial & Last Name & Degree
Adam Cohen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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