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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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 ≥

- 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.

Exclusion Criteria:

- 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
oral vinorelbine.

- 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
supraventricular tachycardia.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

CT scan and MUGA scan

Outcome Time Frame:

Every 9 weeks. Up to 2 years

Safety Issue:


Principal Investigator

Troels Bechmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Vejle Hospital


Denmark: Danish Medicines Agency

Study ID:




Start Date:

November 2010

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Metastatic
  • HER2 positive
  • vinorelbine
  • Breast Neoplasms