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Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer

NCT04083963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-07-10

No results posted yet for this study

Summary

Nonrandomized, open label, single arm, Simon's two stage MinMax design trial of neoadjuvant weekly carboplatin plus paclitaxel, followed by doxorubicin and cyclophosphamide in patients with operable Triple Negative Breast Cancer (TNBC)

Conditions

Interventions

DRUG

Carboplatin

Low dose weekly carboplatin (AUC 2) will be combined with weekly paclitaxel for 12 weeks.

DRUG

Paclitaxel

Paclitaxel will be given weekly along with carboplatin for 12 weeks.

DRUG

Doxorubicin

Dose dense doxorubicin will be administered in combination with cyclophosphamide for 4 cycles after weekly carboplatin/paclitaxel.

DRUG

Cyclophosphamide

Does dense cyclophosphamide will be in combination with doxorubicin for 4 cycles after weekly carboplatin/paclitaxel.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Kent Hoskins, M.D. · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2026-09-27
Completion
2026-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04083963 on ClinicalTrials.gov