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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.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2004-000962-11-CZ
Date of registration:	25/01/2005
Prospective Registration:	Yes
Primary sponsor:	Pierre Fabre Medicament represented by IRPF
Public title:	Phase II Study of Navelbine oral and Arimidex as neo-adjuvant treatment in post-menopausal women with locally advanced breast carcinoma
Scientific title:	Phase II Study of Navelbine oral and Arimidex as neo-adjuvant treatment in post-menopausal women with locally advanced breast carcinoma
Date of first enrolment:	01/03/2005
Target sample size:	62
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000962-11
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: yes 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
Phase:

Countries of recruitment
Czech Republic

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
- Women with a locally advanced measurable (according to RECIST criteria) breast cancer (tumour size >3cm by ultrasound, No-2, M0),
- Previously untreated with chemotherapy, hormonotherapy, radiotherapy or immunotherapy,
- Women defined as post-menopausal
- With WHO performance inferior or equal to 2
- With 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:
- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorptions of oral vinorelbine
- Patient with inflammatory breast carcinoma (T4d) or in ipsilateral, infra/supra clavicular lymph nodes (N3)
- Patient with symptom suggesting brain or leptomeningeal involvment
- Patient treated with any investigational drug within the 30 days prior to registration
- Patient with dysphagia (grade superior or equal to 2) or inability to swallow tablets
- Patient prior to registration, is unwilling to undergo breast surgery at the end of neo-adjuvant treatment
- Clinically significant cardiovascular, hepatic, neurological or other systemic disease
- Unwillingness to sto taking any drug affecting sex hormonal status

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Neo-Adjuvant Treatment in Post-menopausal women with locally advanced breast carcinoma.

Intervention(s)

Trade Name: Navelbine 20 mg,soft capsules
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) -

Trade Name: Arimidex
Product Name: Arimidex, coated tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Anastrozole
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1 -

Trade Name: Navelbine 30 mg, soft capsule
Product Name: Navelbine soft capsule
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Navelbine soft capsules
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30 (41.55)-

Primary Outcome(s)

Main Objective: To assess the efficacy (by ultrasound) of oral vinorelbine and anastrozole combination in terms of down-staging (OR + stage).

Secondary Objective: - To estimate the rate of conservative surgical resection,
- To assess the efficacy (by calliper measurement),
- To assess the pathological complete response (pCR),
- To compare the clinical response by ultrasound and by calliper,
- To estimate the disease free survival,
- To assess the safety.

Primary end point(s): Evaluation of the efficacy (by ultrasound) of oral vinorelbine and anastrozole combination in terms of down-staging (OR + range)

Secondary Outcome(s)

Secondary ID(s)

PM0259CA217B0

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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