A phase II randomised study to investigate the effects of Bevacizumab on cell proliferation and on pCR in patients with locally advanced operable breast cancer - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005048-19-IT

Enrollment

120

Registered

2006-01-31

Start date

2006-04-10

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

histologically proven primary breast cancer 2.0 cm, T2-T3 T4 a-d, N0-2, M0 MedDRA version: 6.1 Level: PT Classification code 10057654

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Solution for infusion Current Sponsor code: RO 4876646-000 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically proven primary breast cancer 2.0 cm, T2-T3 T4 a-d, N0-2, M0 Women aged 18 70 years 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: Patients with overexpression HER2/neu 3 or amplification of HER2/neu gene evaluated by FISH, suitable for Herceptin containing regimens as primary therapy Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV INR greater than 1.50. Prior history of bleeding diathesis or coagulopathy including deep venous thrombosis or pulmonary embolism. Recent within last six months or current history of gastrointestinal bleeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to estimate the effect of Bevacizumab compared withwith No Bevacizumab on the change in tumor cell proliferation by assessment of Ki-67, a biomarker of cell proliferation, in breast cancer tissue at baseline tumor core biopsy and after 24-28 weeks surgical resection specimen of treatment.;Secondary Objective: To assess the effect of 24-28 weeks of Bevacizumab on the change in tumour size as assessed by ultrasound and mammography and on the percentage of pathological complete remissions pCR .;Primary end point(s): The main objective of the study is the comparison between the reduction in ki-67 expression in breast cancer after conventional primary treatment and the reduction in ki-67 expression after a combination of conventional treatment plus bevacizumab.	—

Measure

Time frame

Main Objective: The primary objective of the study is to estimate the effect of Bevacizumab compared withwith No Bevacizumab on the change in tumor cell proliferation by assessment of Ki-67, a biomarker of cell proliferation, in breast cancer tissue at baseline tumor core biopsy and after 24-28 weeks surgical resection specimen of treatment.;Secondary Objective: To assess the effect of 24-28 weeks of Bevacizumab on the change in tumour size as assessed by ultrasound and mammography and on the percentage of pathological complete remissions pCR .;Primary end point(s): The main objective of the study is the comparison between the reduction in ki-67 expression in breast cancer after conventional primary treatment and the reduction in ki-67 expression after a combination of conventional treatment plus bevacizumab.

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Countries

Italy

Outcome results

None listed

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