TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer (ANETT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02988986|
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : July 27, 2021
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Positive Breast Cancer||Drug: TAK-228 Drug: Tamoxifen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 24, 2017|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||March 30, 2019|
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.
Other Name: INK128, MLN0128
Other Name: Apo-Tamox, Gen-Tamoxifen, Nolvadex, Novo-Tamoxifen
- Ki67 Expression [ Time Frame: Baseline to 6 weeks ]Ki67 expression change from baseline to 6 weeks
- Number of Participants Meeting Certain Preoperative Endocrine Prognostic Index (PEPI) [ Time Frame: 16 weeks ]
Evaluate the number of participants meeting certain PEPI score after treatment with TAK-228 plus tamoxifen.
PEPI score of 0 indicates low risk of disease recurrence (better outcome) PEPI score of 1-3 indicates intermediate risk of of disease recurrence (worse outcome) PEPI score of >4 indicates high risk of of disease recurrence (worst outcome)
- Number of Participants With Pathological Complete Response (pCR) [ Time Frame: 16 weeks ]Pathologic complete response was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0 ypN0 or ypTis ypN0 in the current American Joint Committee on Cancer staging system).
- Plasma Concentrations of TAK-228 Plus Tamoxifen [ Time Frame: 16 weeks ]Measure plasma concentrations of TAK-228 plus tamoxifen over time
- Correlation Between Change in Ki67 Expression and pCR to TAK-228 Plus Tamoxifen [ Time Frame: 16 weeks ]Assess the correlation between change in Ki67 expression and pCR to TAK-228 plus tamoxifen
- Correlation Between Tumor Mutational Status and Response to TAK-228 Plus Tamoxifen [ Time Frame: 16 weeks ]Assess correlation between tumor mutational status and response to TAK-228 plus tamoxifen
- Correlation Between Change in mTOR Expression and pCR to TAK-228 Plus Tamoxifen [ Time Frame: 16 weeks ]Assess the correlation between change in mTOR expression and pCR to TAK-228 plus tamoxifen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988986
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Houston Methodist Hospital Willowbrook|
|Houston, Texas, United States, 77070|
|Houston Methodist Hospital Sugar Land|
|Sugar Land, Texas, United States, 77479|
|Principal Investigator:||Jenny C Chang, M.D.||Houston Methodist Cancer Center|