Phase II Study of Navelbine oral and Arimidex as neo-adjuvant treatment in post-menopausal women with locally advanced breast carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000962-11-CZ

Enrollment

Registered

2005-01-25

Start date

2005-03-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026