NCT02988986

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

Open Label, Phase II Trial of Neoadjuvant TAK-228 Plus Tamoxifen in Patients With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The mTOR pathway is commonly dysregulated in ER-positive breast cancers and represents a key resistance mechanism to endocrine therapy such as tamoxifen. We plan to target the mTOR pathway with mTORC1/2 inhibitor TAK-228 to overcome tamoxifen resistance in early-stage ER-positive breast cancer. An open label phase II clinical trial will be conducted to determine the efficacy, toxicity, and safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast cancer. TAK-228 (30 mg weekly) plus tamoxifen (20 mg daily) will be administered for 16 weeks. Patients will undergo tumor biopsy before starting the study treatment and after 6 weeks of study treatment. Blood samples for pharmacokinetics analysis will be obtained 1 hour before and after TAK-228 dosing on days 1 and 15 of the study.

Conditions

• Estrogen Receptor Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	TAK-228	MTORC1/2 inhibitor
DRUG	Tamoxifen	Non-steroidal anti-estrogen

Timeline

• Start date: 2017-04-24
• Primary completion: 2019-02-01
• Completion: 2019-03-30
• First posted: 2016-12-12
• Last updated: 2021-09-22
• Results posted: 2021-07-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study