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TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer

NCT03193853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-08-07

Study results available
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Summary

This study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab paclitaxel in patients with metastatic triple negative breast cancer.

Conditions

Interventions

DRUG

Tak-228 & Tak-117

Patients will receive 4mg oral TAK-228 and 200mg TAK-117 tablets until disease progression.

DRUG

Cisplatin & Nab Paclitaxel

following Tak-228 \& Tak-117 standard nab paclitaxel 175-220 mg/m2 plus cisplatin 60-75 mg/m2 infusion for six cycles. Patients who did not progress may continue nab paclitaxel under treating physicians discretion

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Joyce O'Shaughnessy

    lead OTHER

Principal Investigators

  • Joyce O'Shaughnessy, MD · Baylor Scott & White Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2020-03-17
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03193853 on ClinicalTrials.gov