Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer

Inclusion Criteria

• •Woman ≥ 18 years of age.
• •PS 0-2. Expected lifetime of more than 12 weeks.
• •Histologically verified breast cancer(adenocarcinoma)
• •Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2).
• •Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy.
• •The patient may have received (neo-) adjuvant chemotherapy (taxanes, anthracyclines and trastuzumab) and 1st line chemotherapy in combination with trastuzumab for metastatic disease.
• •The patient may have received previous adjuvant antihormonal treatment for metastatic breast cancer.
• •The patient may receive radiation therapy, however, not against lesions used for response evaluation.
• •Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO.
• •Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
• •Normal liver function: Bilirubin ≤ 1.5 x upper normal level, ALAT ≤ 2.5 x upper normal level, BASP ≤ 2.5 x upper normal level (≤ 5 if presence of bone metastases).
• •Normal renal function: Creatinine ≤ upper normal level. In case of raised creatinine the measured/calculated GFR must be ≥ 50 ml/min.
• •Fertile women must present a negative pregnancy test and use contraceptives during and 3 months after treatment. An IUD without hormone is considered a safe contraceptive.
• •Written and orally informed consent prior to any study related procedure.