TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer
Lay Description
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
- Cancers and Other Neoplasms
- IRB Number
- 20170565HU
- NCT Number
- NCT02988986
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
1. Female or male = 18 years of age. 2. Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as = 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show: - IHC 1+ or 0 - In situ hybridization negative based on: - Single-probe average HER2 copy number < 4.0 signals/cell - Dual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell. 3. Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation. 4. Eastern Cooperative Oncology Group performance status and/or other performance status of = 1. 5. Female patients who: - Are postmenopausal for at least 1 year before the screening visit, OR - Are surgically sterile, OR - If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the ICF through 90 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International, summary of product characteristics, etc.] after the last dose of the study drugs, OR - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together). 6. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: - Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of the study drugs, OR - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient - Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs. 7. Screening clinical laboratory values as specified below: 1. Bone marrow reserve consistent with: absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, and hemoglobin = 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs; 2. Hepatic status: Serum total bilirubin = 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase = 1.5 x ULN, and alkaline phosphatase = 1.5 x ULN; 3. Renal status: Creatinine clearance =50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour); 4. Metabolic status: HbA1c < 7.0%, fasting serum glucose = 130 mg/dL, and fasting triglycerides = 300 mg/dL. 8. Ability to swallow oral medications. 9. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 10. Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential. 11. Patient must be accessible for treatment and follow-up. 12. Patient must be willing to undergo breast biopsies as required by the study protocol.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
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
Principal Investigator
Virginia Kaklamani