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LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer

NCT04762901 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-26

No results posted yet for this study

Summary

This is an open-label, two-stage, multi-arm Phase 1 study designed to evaluate the safety and preliminary efficacy of combining niraparib with four standard chemotherapy regimens used to treat TNBC.

Conditions

Interventions

DRUG

Niraparib

Oral tablet

DRUG

Doxorubicin

IV

DRUG

Cyclophosphamide

IV

DRUG

Paclitaxel

IV

DRUG

Pegfilgrastim

Injection

DRUG

Carboplatin

IV

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Antoinette Tan, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

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Drugs
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 NCT04762901 on ClinicalTrials.gov