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TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer

NCT02988986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-09-22

Study results available
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Summary

This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast cancer.

Conditions

  • Estrogen Receptor Positive Breast Cancer

Interventions

DRUG

TAK-228

MTORC1/2 inhibitor

DRUG

Tamoxifen

Non-steroidal anti-estrogen

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Jenny C Chang, M.D. · Houston Methodist Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2019-02-01
Completion
2019-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02988986 on ClinicalTrials.gov