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

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda); Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01941771

EUDRACT nr. 2011-003564-72

2011-003564-72 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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).

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Arm A

Active Comparator group

Description:

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.

Treatment:

Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Arm B

Experimental group

Description:

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.

Treatment:

Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)