Purpose

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.

Category

IRB Number
20170565HU
NCT Number
NCT02988986
Sponsor
Jenny C. Chang, MD -



Study Contact

Principal Investigator
Virginia Kaklamani

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Estrogen Receptor Positive Breast Cancer

      2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      TAK-228 Plus Tamoxifen

      		TAK-228 will be orally administered at 30 mg weekly for 16 weeks. Tamoxifen will be orally administered at 20 mg daily for 16 weeks.
    2. Drug: Tamoxifen

      Non-steroidal anti-estrogen

      Other names:

      • Apo-Tamox, Gen-Tamoxifen, Nolvadex, Novo-Tamoxifen

    3. Drug: TAK-228

      MTORC1/2 inhibitor

      Other names:

      • INK128, MLN0128

      4.