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
Open to Enrollment
Yes
Sponsor
Jenny C. Chang, MD -



Study Contact

Principal Investigator
Virginia Kaklamani

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Virginia Kaklamani
(210) 450-3838
kaklamani@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
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.
    3. Drug: Tamoxifen

      Non-steroidal anti-estrogen

      Other names:

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

    4. Drug: TAK-228

      MTORC1/2 inhibitor

      Other names:

      • INK128, MLN0128