Please assess the completion status of the following clinical trial:

Trial Title: Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ 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 patients, age at diagnosis 18 - 75 years~2. Histological confirmed unilateral primary invasive carcinoma of the breast~3. Clinical Stage Tumor 1 (cT1) (\> 1 cm) - Clinical Stage Tumor 4 (cT4) (if operable, inflammatory breast cancer is excluded)~4. HER2 over-expressing tumor confirmed by: 3+ by Immuno-histochemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization \[Fluorescent In-Situ Hybridization (FISH), Chromogenic In-Situ Hybridization (CISH) or Silver In-Situ Hybridization (SISH); \> 6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥ 2.0\]~5. Clinically node positive disease or node negative disease~6. No clinical evidence for distant metastasis (cM0) after conventional staging~7. Performance Status Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky Index (KI) ≥ 80%~8. Baseline Left Ventricular Ejection Fraction (LVEF) \> 50% measured by echocardiography~9. Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients~10. The patient must be accessible for treatment and follow-up~11. Written informed consent including a written informed consent for shipping of tumor block for central pathology review and evaluation prior to the start of any study procedures~Exclusion Criteria:~1. Known hypersensitivity reaction to the compounds or incorporated substances~2. Known polyneuropathy grade ≥ 2~3. Have acute or currently active or requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment).~4. Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri~5. Prior or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor~6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry~7. Male breast cancer~8. Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment~9. Breast feeding women~10. Sequential breast cancer~11. Lack of patient compliance~12. Inadequate organ function including:~    * Leucocytes \< 3.5 x 109/l~   * Platelets \< 100 x 109/l~   * Absolute Neutrophil Count (ANC) \< 1.5 x 109/l~   * Hemoglobin \< 9 g/dl~   * Serum Creatinine \> 1.5 mg/dl~   * Serum Bilirubin \> 1.1 mg/dl~   * Alkaline phosphatase \> 2.5 x Upper Limit of Normal (ULN)~   * Aspartate Transaminase (ASAT) and/or Alanine Transaminase (ALAT) \> 2.5 ULN~   * Albumin \< 2.5 g/dl~13. Uncompensated cardiac function~14. Malabsorption syndrome, disease significantly affecting gastrointestinal function~15. Concomitant use of Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Paclitaxel + Lapatinib + Trastuzumab (Type: EXPERIMENTAL): Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment

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

Answer: outcome: terminate
termination_type: lack of efficacy