Please assess the completion status of the following clinical trial:

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

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
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:~1. Any patient with metastatic disease.~2. Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.~3. Known human immunodeficiency virus infection.~4. Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.~5. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.~6. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.~7. Breastfeeding or pregnant.~8. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or an unknown reason that may alter the absorption of TAK-228. Patients with enteric stomata are also excluded.~9. Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.~10. Poorly controlled diabetes mellitus (defined as HbA1c \> 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.~11. History of any of the following within the last 6 months before administration of the first dose of the study drugs:~    * Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures~   * Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures~   * Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, and ventricular tachycardia)~   * Placement of a pacemaker for control of rhythm~   * New York Heart Association Class III or IV heart failure~   * Pulmonary embolism~12. Significant active cardiovascular or pulmonary disease including:~    * Uncontrolled hypertension (i.e., systolic blood pressure \> 180 mm Hg, diastolic blood pressure \> 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.~   * Pulmonary hypertension~   * Uncontrolled asthma or O2 saturation \< 90% by arterial blood gas analysis or pulse oximetry on room air~   * Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement~   * Medically significant (symptomatic) bradycardia~   * History of arrhythmia requiring an implantable cardiac defibrillator~   * Baseline QTc prolongation (e.g., repeated demonstration of QTc interval \> 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)~13. Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.~14. Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.~15. Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.~16. Patients unwilling or unable to comply with the study protocol.~17. Patients previously treated with hormonal therapy (tamoxifen, AI) or PI3K, AKT, dual PI3K/mTOR, TORC1/2, or mTORC1 inhibitors.~18. Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.~19. Patients with hypersensitivity to mTOR inhibitors or tamoxifen.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- TAK-228 Plus Tamoxifen (Type: EXPERIMENTAL): 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.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete