- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722968
A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel (BEVPAC)
A Prospective Randomized Phase II Study to Identify Predictive Biomarkers and Mechanisms of Therapy Resistance in Patients With HER2-negative Metastatic Breast Cancer Treated With the Combination of Bevacizumab and Paclitaxel (BEVPAC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total of 30 patients will be included during a period of 2 years.
The study will be initiated with a non-randomized, feasibility stage including ten patients who will be treated with bevacizumab and paclitaxel, in order to determine the safety of metastatic tumor biopsies during therapy with bevacizumab.
In the second phase, patients will be randomized (1:1) between two treatment arms: A. Bevacizumab + paclitaxel and B. Paclitaxel
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Stockholm
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Solna, Stockholm, Sweden, 17176
- Karolinska University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-70 years.
- Performance status ECOG 0-2.
- Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
- At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria. At least one site of disease must be unidimensionally measurable as follows:
- CT-scan, physical exam ≥ 10 mm} Chest X-ray ≥ 20 mm }see Eisenhauer et al. for more details
- Lymph node short axis ≥ 15 mm }
- All radiology studies must be performed within 28 days prior to registration (35 days if negative).
Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
- Haematology: Absolute granulocytes > 1.5 x 109/L Platelets > 100 x 109/L
- Biochemistry:Bilirubin within normal limits Serum creatinine within normal limits
- APTT and INR within normal limits within 7 days prior to enrollment.
- Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) within normal limits determined by echocardiogram or MUGA within 28 days prior to inclusion.
- Written informed consent must be given.
Exclusion Criteria:
- Previous systemic treatment for MBC.
- Major surgery less than 28 days prior to enrollment.
- Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
- Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
- Major cardiac comorbidity.
- Previous treatment with bevacizumab.
- Previous allergic reaction to taxane analogs.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A
Arm A and feasibility phase: Bevacizumab 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly.
|
15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly
Other Names:
80mg/m2 iv weekly
Other Names:
|
Active Comparator: Arm B
Arm B: Paclitaxel 80mg/m2 iv weekly.
|
80mg/m2 iv weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of molecular biomarkers
Time Frame: After the study completion,After completion of the study, which will take up to 3 years
|
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative MBC.
|
After the study completion,After completion of the study, which will take up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of metastatic biopsies during bevacizumab therapy
Time Frame: continuous assessment and after inclusion of 10 patients, After completion of the study which will take up to 1 year
|
The safety objective of the study is to assess whether carrying out metastatic tissue biopsies during treatment with bevacizumab is safe.
For this reason, the study will be initiated with a feasibility phase of 10 patients and will be continued to the randomized phase only if the study specific procedures prove to be safe.
|
continuous assessment and after inclusion of 10 patients, After completion of the study which will take up to 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Molecular changes by bevacizumab
Time Frame: After completion of the study which will take up to 3 years
|
To identify molecular changes in the tumor induced by the addition of bevacizumab to chemotherapy.
|
After completion of the study which will take up to 3 years
|
Efficacy of bevacizumab
Time Frame: After completion of the study, After completion of the study, which will take up to 3 years
|
To measure the efficacy of bevacizumab in combination with paclitaxel in HER2 negative MBC.
|
After completion of the study, After completion of the study, which will take up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theodoros Foukakis, MD PhD, Karolinska University Hospital
- Study Director: Jonas Bergh, Professor, Karolinska University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- EudraCT no: 2012-003743-30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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