A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel

NCT ID: NCT01722968

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

Brief Summary

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 metastatic breast cancer (MBC).

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Arm A and feasibility phase: Bevacizumab 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly.

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly

Paclitaxel

Intervention Type: DRUG

80mg/m2 iv weekly

Arm B

Arm B: Paclitaxel 80mg/m2 iv weekly.

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

80mg/m2 iv weekly

Interventions

Bevacizumab

15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly

Intervention Type: DRUG

Paclitaxel

80mg/m2 iv weekly

Intervention Type: DRUG

Other Intervention Names

Avastin; Paxene; Taxol

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 years.

2. Performance status ECOG 0-2.

3. Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.

4. At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.

5. 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:

1. CT-scan, physical exam ≥ 10 mm} Chest X-ray ≥ 20 mm }see Eisenhauer et al. for more details

2. Lymph node short axis ≥ 15 mm }

3. All radiology studies must be performed within 28 days prior to registration (35 days if negative).

6. Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:

1. Haematology: Absolute granulocytes > 1.5 x 109/L Platelets > 100 x 109/L

2. Biochemistry:Bilirubin within normal limits Serum creatinine within normal limits

7. APTT and INR within normal limits within 7 days prior to enrollment.

8. Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) within normal limits determined by echocardiogram or MUGA within 28 days prior to inclusion.

9. Written informed consent must be given.

Exclusion Criteria

1. Previous systemic treatment for MBC.

2. Major surgery less than 28 days prior to enrollment.

3. 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.

4. Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.

5. Major cardiac comorbidity.

6. Previous treatment with bevacizumab.

7. Previous allergic reaction to taxane analogs.

8. Ongoing pregnancy or lactation.

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodoros Foukakis

OTHER

Sponsor Role: lead

Responsible Party

Theodoros Foukakis

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Theodoros Foukakis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Jonas Bergh, Professor

Role: STUDY_DIRECTOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Solna, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

EudraCT no: 2012-003743-30

Identifier Type: -

Identifier Source: org_study_id