Randomised phase II study of the combination of oral vinorelbine with capecitabine versus a sequential regimen of oral vinorelbine and capecitabine versus the combination of docetaxel and capecitabine in patients with metastatic breast cancer previously treated with anthracyclines.

• Register: EUCTR
• Last refreshed on: 29 April 2013
• Main ID: EUCTR2004-005205-30-AT
• Date of registration: 22/11/2005
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament
• Public title: Randomised phase II study of the combination of oral vinorelbine with capecitabine versus a sequential regimen of oral vinorelbine and capecitabine versus the combination of docetaxel and capecitabine in patients with metastatic breast cancer previously treated with anthracyclines.
• Scientific title: Randomised phase II study of the combination of oral vinorelbine with capecitabine versus a sequential regimen of oral vinorelbine and capecitabine versus the combination of docetaxel and capecitabine in patients with metastatic breast cancer previously treated with anthracyclines.
• Date of first enrolment: 27/12/2005
• Target sample size: 135
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005205-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
- Females with histologically or cytologically confirmed adenocarcinoma of the breast and documented metastatic disease
- HER-2 negative disease on the primary tumour or on metastatic site
- At least one measurable lesion according to RECIST
- Prior (neo)-adjuvant chemotherapy (anthracycline-based, unless contraindicated) with at least 12 months of disease-free interval. In case of prior taxane chemotherapy in the (neo) adjuvant setting at least twelve months of disease free interval will be required
- No prior chemotherapy for metastatic disease
- Patients may have received prior radiotherapy but not to the sites used to assess response. A minimum 4-week interval must have elapsed unless the area involved was < 20 % of bone marrow volume in which case the patient may start treatment earlier
- Patients may have had previous hormonal therapy as adjuvant treatment and/or treatment of metastatic disease provided that the patient has progressive disease at study entry. Hormonal therapy must be discontinued prior to study entry
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) during the treatment and must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
- Age not less than 18 and not more than 75 years
- Life expectancy of at least 3 months
- Karnofsky performance status of 70 or greater
- Adequate haematological, hepatic and renal functions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Female is not eligible to enter the study if :
- pregnant or lactating-
- with positive pregnancy test at inclusion
- Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy treatment
- HER-2 positive disease on the primary tumour or on metastatic site
- Prior vinorelbine containing regimen in the (neo)-adjuvant setting
- Patient with life-threatening conditions (i.e. symptomatic lung lymphangitis, rapidly progressive visceral lesions)
- History of another malignancy except appropriately-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix during the last 5 years
- Malabsorption syndrome or disease affecting significantly gastrointestinal tract function
- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- Patients with brain or leptomeningeal metastases
- Prior severe and unexpected reaction to fluoropyrimidine therapy (which can be explained by DPD deficiency) or known hypersensitivity to 5-fluorouracil, or capecitabine
- Patients with prior history of severe hypersensitivity to drugs formulated with polysorbate 80
- Patients with prior history of high-dose chemotherapy followed by bone marrow or peripheral stem cell support
- Concomitant treatment with sorivudine or its clinically related analogues such as brivudine
- Concurrent treatment with any other anti-cancer therapy
- Patients with pre-existing motor or sensory peripheral neuropathy grade not less than 2 according to NCI criteria
- Male patients.


Age minimum:
Age maximum:
Gender:
Female: yes
Male:

Health Condition(s) or Problem(s) studied

Patients with metastatic breast cancer previously treated with anthracyclines

Intervention(s)

Trade Name: Navelbine oral Kapseln
Product Name: Navelbine Soft Capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20 (27.70)-
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30 (41.55)-

Trade Name: Xeloda
Product Name: Xeloda
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150-
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-

Primary Outcome(s)

Secondary Objective: - to evaluate the duration of response, the progression-free survival, time-to-treatment failure and overall survival
- to evaluate the safety profile in the 3 study arms
- to assess the quality of life

Main Objective: To evaluate simultaneously the response rate of the combination of oral vinorelbine with capecitabine, a sequential regimen of oral vinorelbine and capecitabine, and the combination of docetaxel and capecitabine for first line treatment of patients with metastatic breast cancer, after prior anthracycline containing (neo)- adjuvant regimen

Primary end point(s): - Assessment of all lesions every 2 cycles according to RECIST
- Assessment of the tumour response rate, duration of responses progression free survival, time to treatment failure and overall survival

Secondary ID(s)

PM0259CA222B0