Breast Cancer
Conditions
Keywords
Breast cancer, Metronomic chemotherapy, Vinorelbine, Navelbine, Capecitabine, Xeloda, Antineoplastic Agents
Brief summary
The study hypothesis is that metronomic treatment is more efficient than standard treatment.
Detailed 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).
Interventions
DRUGArm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
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.
DRUGArm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
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.
Sponsors
Pierre Fabre Laboratories
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint is overall response rate i both arms. | up to 60 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression. | up to 60 month | Number of days from start of treatment to progression of disease assessed up to 60 months |
| Overall survival. | up to 60 month | Number of days from start of treatment to death assessed up to 60 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | Side effects of treatment | Monitoring side effects of treatment assessed up to 60 months. |
Countries
Denmark
Outcome results
None listed