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A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

NCT04102618 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-08-15

No results posted yet for this study

Summary

The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated.

Conditions

Interventions

BIOLOGICAL

Pelareorep

4.5 × 10e10 TCID50 administered intravenously on Days 1, 2, 8 \& 9

DRUG

Letrozole

Oral dose of 2.5 mg/day starting on Day 3 for 13 days

DRUG

Atezolizumab

1200 mg administered intravenously on Day 3

DRUG

Trastuzumab

8mg/kg administered intravenously or 600mg subcutaneously on Day 3

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2022-04-20
Completion
2022-04-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04102618 on ClinicalTrials.gov