A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer
- 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
- The patient may have received previous adjuvant antihormonal treatment for metastatic
- The patient may receive radiation therapy, however, not against lesions used for
- Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO.
- Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10^9/l. Thrombocytes ≥
- 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
- Written and orally informed consent prior to any study related procedure.
- Local recurrence or counter-lateral breast cancer without other dissemination.
- Pregnant or breastfeeding women.
- Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis.
- Malabsorption syndrome or other disease affecting the gastrointestinal function.
Resection of the ventriculus or the small intestine, which can affect absorption of
- Dysphagia or other conditions preventing the patient from swallowing tablets.
- Mental or social conditions preventing treatment or follow-up.
- Serious concurrent medical condition, such as:
- AMI within 12 months or unstable angina.
- Heart incompensation NYHA III or IV or uncontrolled hypertension (systolic > 150
mm/hg and/or diastolic >100 mm/hg).
- Serious arrythmia requiring medication, excl. atrial fibrillation and paroxystic
- Active infection, uncontrolled diabetes or hypercalcemia.
- Other concurrent experimental treatment.
- Concurrent antihormonal treatment of metastatic breast cancer.
- Known neuropathia ≥ grade 2.
- Other previous malignant disease within the past 5 years excl. non-melanoma skin
cancer and carcinoma in situ cervicis uteri.
- Previous treatment with vinca alkaloid.
- Previous serious allergic or unexpected reactions to trastuzumab treatment.