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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 July 2020 |
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Main ID: |
EUCTR2004-000748-26-ES |
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Date of registration:
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13/10/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicable
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Scientific title:
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Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicable |
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Date of first enrolment:
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08/11/2004 |
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Target sample size:
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55 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000748-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Women with age not less than 18 years,
Documented metastatic breast disease previously untreated by chemotherapy,
HER2 positive (assessed by 3+IHC or FISH+) on the primary tumor or on metastatic site,
At least one measurable lesion using the RECIST criteria,
Be ambulatory with a Karnofsky Performance Status not less than 70%,
Life expectancy not less than 16 weeks,
Normal cardiac function, LVEF not less than 50% as measured by MUGA scan or ultrasound,
Adequate bone marrow, 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:
Local relapse alone after conservative treatment of contra-lateral tumor,
Pregnant or lactating women,
Patient with symptoms suggesting CNS involvment or leptomeningeal metastases,
Concomitant hormone therapy for metastatic breast cancer,
Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine (Xeloda) and oral vinorelbine (Navelbine Oral),
Other serious illness or medical conditions.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Treatment in women with previously untreated HER2 positive metastatic breast cancer.
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Intervention(s)
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Trade Name: Navelbine Cápsulas Blandas
Product Name: Navelbine Cápsulas Blandas
Product Code: Not applicable
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: Not applicab
Current Sponsor code: Not applicable
Other descriptive name: Not applicable
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20 (27.70)-30 (41.55)
Trade Name: Xeloda 500 mg 120 commprimidos cubierta pelicular
Product Name: Xeloda
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
CAS Number: Not applicab
Current Sponsor code: Not applicable
Other descriptive name: Not applicable
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Trade Name: Herceptin 150 mg
Product Name: Herceptin 150 mg
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Trastuzumab
CAS Number: Not applicab
Current Sponsor code: Not applicable
Other descriptive name: Not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
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Primary Outcome(s)
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Primary end point(s): Evaluation of the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.
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Secondary Objective: - To assess the safety profile of the combination,
- To evaluate other efficacy parameters of the combination:
- Progression free survival,
- Duration of response,
- Time to treatment failure,
- Overall survival.
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Main Objective: To evaluate the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.
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Secondary ID(s)
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PM0259CA215B0
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Not applicable
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 30/07/2004
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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