Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer (OVINTRA)

May 20, 2015 updated by: Vejle Hospital

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Aalborg, Denmark, 9000
    - Dept. of Oncology, Aalborg Sygehus
  - Esbjerg, Denmark, 6700
    - Dept. of Oncology, Esbjerg Hospital
  - Vejle, Denmark, DK-7100
    - Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate Time Frame: Every 9 weeks. Up to 2 years	CT scan and MUGA scan	Every 9 weeks. Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival Time Frame: Every 9 weeks from date of first treatment until progression or death. Up to 2 years	CT scan	Every 9 weeks from date of first treatment until progression or death. Up to 2 years
Overall Survival Time Frame: From date of inclusion until date of death. Up to 2 years.		From date of inclusion until date of death. Up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

Principal Investigator: Troels Bechmann, MD, Department of Oncology, Vejle Hospital
Study Chair: Erik H Jakobsen, MD, Department of Oncology, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria