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A Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter

NCT02988648 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-22

No results posted yet for this study

Summary

The purpose of this phase I/II study is to evaluate the safety and clinical activity of Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that overexpresses functional Na/I symporter. The study will enroll patients with metastatic breast cancer who have had clinical and/or radiographic evidence of disease progression on prior hormonal and/or chemotherapy.

Conditions

Interventions

RADIATION

Radioiodide (131I-)

The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Lajos Pusztai, M.D., D.Phil · Yale University: Professor of Medicine, Section of Medical Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02988648 on ClinicalTrials.gov