Safety and Efficacy of Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Sponsor
- Emory University
- Locations
- 1
- Primary Endpoint
- Liver and overall progression free survival (PFS)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd or 3rd line therapy for treating patients with breast cancer that has spread to the liver (metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by assessing progression free survival (PFS). SECONDARY OBJECTIVES: I. To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by evaluating treatment related toxicities and identifying baseline predictors of treatment related toxicity. II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus (vs.) non-TNBC on PFS and toxicity. III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others. IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic therapy. V. To evaluate compare inflammatory changes in the in the targeted tumors before and after Y90 radioembolization for identification of potential synergistic immunotherapy pathways. VI. To identify genetic biomarkers of treatment response to Y90 radioembolization. VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a tool to objectively quantify baseline and post treatment hepatic dysfunction. VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease course. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization. ARM II: Patients receive systemic therapy. After completion of study treatment, patients are followed up at 4-8 weeks, and then every 12-16 weeks for 2 years.
Investigators
Nima Kokabi
Principal Investigator
Emory University
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •Age \>= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine genetic profiling) if not performed before, the biopsy will be performed at the time of shunt of study/mapping.
- •The metastatic breast cancer to the liver or the primary metastatic breast cancer with one of the following receptor profiling:
- •Triple Negative Breast Cancer (TNBC) (i.e ER-, PR-, HER2-);
- •ER+, PR+, HER2-;
- •ER+, PR-, HER2-;
- •ER-, PR+, HER2-. HER2 negative breast cancer is defined as IHC result of 0 or 1+ in a core needle biopsy specimen of primary breast cancer.
- •Tumor burden =\< 50% of liver
Exclusion Criteria
- •HER2+ breast cancer regardless of ER and PR status.
- •Patients who have had chemotherapy or within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1)
- •Patients who are receiving any other investigational agents or an investigational device within 14 days before starting treatment
- •Any prior liver directed intervention (surgical or liver directed therapy for metastatic breast cancer)
- •Extrahepatic disease (other than permissible criteria described above).
- •Patient with insurance denial for Y90 treatment Consented participants for which Y90 treatment pre-certification was not obtained. This subjects will be considered as a screen failure.
Outcomes
Primary Outcomes
Liver and overall progression free survival (PFS)
Time Frame: From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months
Progression of disease is defined objectively by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using magnetic resonance imaging (MRI) or computed tomography (CT) and/or by positron emission tomography (PET) using PET Response Criteria in Solid Tumors (PERCIST) criteria. PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Secondary Outcomes
- Liver progression free survival (PFS)(From date of randomization to date of liver progression or death, where those alive without liver progression are censored at date of last imaging scan, assessed up to 24 months)