Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

Phase 2CompletedNCT01941771

University of Aarhus110 enrolled

Overview

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status \< 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Breast Cancer

Interventions

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)DRUG

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)DRUG

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer * WHO performance status \< 3 Exclusion Criteria: * Former treatment with Capecitabine or Vinorelbine * Patients who have received more than one line of chemotherapy for metastatic disease * Brain metastases * Malabsorption syndrome * Abnormal organ function * pregnant or lactating women

Locations (1)

Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus C, Denmark

Outcomes

Primary Outcomes

Primary endpoint is overall response rate i both arms.

Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.

Time frame: up to 60 month

Secondary Outcomes

Time to progression.

Number of days from start of treatment to progression of disease assessed up to 60 months

Time frame: up to 60 month

Overall survival.

Number of days from start of treatment to death assessed up to 60 months.

Time frame: up to 60 month

Data from ClinicalTrials.gov

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