Please assess the completion status of the following clinical trial:

Trial Title: Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Female patients with a histologically or cytologically confirmed adenocarcinoma of the breast progressing from prior hormonal therapy~2. Receptor positive disease (ER+ and/or PgR+)~3. HER2 negative~4. Pre- and post-menopausal status~5. Documented disease progression after first-line hormone therapy~6. Age ≥18 years.~7. Measurable or evaluable metastatic disease~8. Life expectancy \> 3 months~9. ECOG Performance Status \< 1~10. Adequate bone marrow, liver, and renal function as assessed by the following parameters:~    * Hemoglobin \> 9.0 g/dl~   * Leucocytes count ≥ 3,000/mL~   * Absolute neutrophil count (ANC) ≥ 1.500/mL~   * Platelet count ≥ 100,000/mL~   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)~   * Albumine and total bilirubin ≤ 1.5 x ULN~   * Prothrombin Time (PT) \< 70 %~   * Serum creatinine \< 1.4 mg/ml, creatinine clearance \> 70 ml/min~11. Normal Respiratory Function and Saturation level ≥ 90%~12. New York Hearth Association (NYHA) Classification ≤ 2 and baseline left ventricular ejection fraction (LVEF)≥ 50%~13. Patients must be willing and able to sign a written informed consent.~Exclusion Criteria:~1. Previous or concomitant treatment with lapatinib and/or metformin~2. More than one line of prior hormone therapy for metastatic breast cancer.~3. More than two lines of prior chemotherapy for metastatic breast cancer~4. Unique location of disease local-regionally treated (surgery, radiotherapy , other)~5. Disease progression not documented or less than 30%~6. Metastatic disease defined as aggressive at investigator's judgement (e.g. visceral disease more than \>1/3 of involved parenchyma, symptomatic disease requiring intensive supportive measures or therapies not allowed by protocol)~7. Patients with brain metastasis~8. Osteosclerotic bone metastasis as unique disease site~9. Pathological tumor markers as unique sign of progressive disease~10. Concomitant treatment with any other anticancer drugs (biphosphonates are permitted)~11. Serious, not solved or unstable toxicity from previous treatment~12. Diabetes mellitus Type I and Type II~13. Renal insufficiency (creatinine ≥ 1.4 mg/ml)~14. Malabsorption syndrome or diseases that significantly may alter gastroenteric functions~15. Other serious illness or medical conditions judged by the investigator to be clinically significant that may adversely affect patient's participation in the trial or interfere with safety profile~16. Active clinically significant or uncontrolled infections (bacterial or viral)~17. Known history of unstable angina (angina symptoms at rest), cardiac ventricular arrhythmias clinically significant, myocardial infarction, stroke or congestive heart failure within 12 months prior to randomization~18. History of lactic acidosis~19. Evidence or symptoms of hepatic insufficiency~20. Chronic alcoholism~21. Concomitant treatment with amiodarone or any other agent that could interfere with study drugs~22. Known or suspected hypersensitivity or allergy to lapatinib, metformin or used excipients~23. Women who are pregnant or lactating~24. History of previous cancer, unless at low risk of relapse per investigator's judgement

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

Study Arms:
- ARM A - Lapatinib (Type: OTHER): hormonal therapy + lapatinib (1250mg/die) until disease progression or extraordinary medical circumstances occur or intolerable toxicities occur or the patient withdraws consent.
- ARM B - Metformin (Type: OTHER): Hormonal therapy + metformin until disease progression or extraordinary medical circumstances occur or intolerable toxicities occur or the patient withdraws consent.
- ARM C - Lapatinib + Metformin (Type: OTHER): Hormonal therapy + lapatinib + metformin until disease progression or extraordinary medical circumstances occur or intolerable toxicities occur or the patient withdraws consent.

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

Answer: outcome: terminate
termination_type: enrollment issues