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Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients

NCT02499367 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-03-22

No results posted yet for this study

Summary

This is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab).

For the second stage, the number of arms will be reduced based on the results obtained in the first stage.

Conditions

Interventions

DRUG

Nivolumab

nivolumab 3 mg/kg, every 2 weeks after induction treatment

RADIATION

Radiation therapy

20 Gy to metastatic lesion

DRUG

Low dose doxorubicin

15 mg flat dose, once weekly for 2 weeks

DRUG

Cyclophosphamide

metronomic schedule, 50 mg daily orally for 2 weeks

DRUG

Cisplatin

40 mg/m2, weekly for 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Marleen Kok, MD · Antoni van Leeuwenhoek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2023-12-31
Completion
2025-08-31

Countries

  • Netherlands

Study Locations

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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 NCT02499367 on ClinicalTrials.gov