Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy

NCT05315687 | Withdrawn Phase 2 DMC FDA Device

• 4 other identifiers: STUDY00002373NCI-2021-03144RAD5251-21P30CA138292
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Carcinoma in the Liver; Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Liver and overall progression free survival (PFS)

  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.

  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

Secondary Outcomes (1)

• 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

Study Arms (2)

Arm I (systemic therapy, Y90 radioembolization)

EXPERIMENTAL

Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization.

Device: Y-90 SIR-Spheres; Procedure: Yttrium-90 Microsphere Radioembolization; Other: Systemic Therapy

Arm II (systemic therapy)

ACTIVE COMPARATOR

Patients receive systemic therapy.

Other: Systemic Therapy

Interventions

Y-90 SIR-Spheres DEVICE

Y-90 SIR-Spheres

Arm I (systemic therapy, Y90 radioembolization)

Yttrium-90 Microsphere Radioembolization PROCEDURE

Undergo Y90 radioembolization

Also known as: Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

Arm I (systemic therapy, Y90 radioembolization)

Systemic Therapy OTHER

Systemic Therapy

Arm I (systemic therapy, Y90 radioembolization); Arm II (systemic therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: 1. Triple Negative Breast Cancer (TNBC) (i.e ER-, PR-, HER2-); 2. ER+, PR+, HER2-; 3. ER+, PR-, HER2-; 4. 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
• Baseline HIDA scan demonstrating normal liver function
• No radiographic, clinical or biopsy evidence of cirrhosis
• Patients to be enrolled in either arm of the study should be deemed appropriate candidate for permissible lines of systemic therapies
• If applicable, patients must have stable brain metastasis (mets) defined as unchanged CNS disease in the past 6 months.
• Life expectancy \> 12 weeks as determined by the Investigator
• Hemoglobin \>= 8.0 g/dl (within 28 days of cycle 1 day 1)
• White blood cell (WBC) \>= 1500/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
• Absolute neutrophil count (ANC) \>= 1,000/mcL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
• Platelets \>= 50,000/mcL (no transfusions allowed within 7 days of day 1 to meet entry criteria) (within 28 days of cycle 1 day 1)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• Sirtex Medical: collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Wu R, Gogineni K, Meisel J, Szabo S, Thirunavu M, Friend S, Bercu Z, Sethi I, Natarajan N, Switchenko J, Levy J, Abdalla E, Weakland L, Kalinsky K, Kokabi N. Study Protocol: Efficacy and Safety of Radioembolization (REM) as an Early Modality (EM) Therapy for Metastatic Breast Cancer (BR) to the Liver with Y90 (REMEMBR Y90). Cardiovasc Intervent Radiol. 2022 Nov;45(11):1725-1734. doi: 10.1007/s00270-022-03254-4. Epub 2022 Aug 25.

  PMID: 36008574 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nima Kokabi

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 7, 2022
• Study Start: August 17, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

US (1)