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ImmunoBreast - A Phase Ib Study

NCT04609215 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-20

No results posted yet for this study

Summary

A phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer.

Conditions

Interventions

OTHER

ALECSAT

Patients will receive concurrent chemotherapy with carboplatin/gemcitabine with cycles repeated every 3 weeks. During the loading phase, patients will receive ALECSAT at 28 days intervals at weeks 5, 9, and 13. Hereafter (the maintenance phase), ALECSAT will be administered every 12 weeks until disease progression, death, unacceptable toxicity, investigator/patient decision or EOT visit at 18 months.

Sponsors & Collaborators

  • CytoVac A/S

    collaborator INDUSTRY

  • National Board of Health, Denmark

    collaborator OTHER_GOV

  • Henrik Ditzel

    lead OTHER

Principal Investigators

  • Anette R Kodahl, MD, PhD · Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2023-05-21
Completion
2023-05-21

Countries

  • Denmark

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 NCT04609215 on ClinicalTrials.gov