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

University of Aarhus logo

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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