Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer

NCT ID: NCT01242449

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-10-31

Brief Summary

This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.

Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Trastuzumab

Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks

Intervention Type: DRUG

Vinorelbine

Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Troels Bechmann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Vejle Hospital

Erik H Jakobsen, MD

Role: STUDY_CHAIR

Department of Oncology, Vejle Hospital

Locations

Dept. of Oncology, Aalborg Sygehus

Aalborg, , Denmark

Dept. of Oncology, Esbjerg Hospital

Esbjerg, , Denmark

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

2010-021618-42

Identifier Type: -

Identifier Source: org_study_id