NCT01722968

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

5.6 years

First QC Date

October 22, 2012

Last Update Submit

February 25, 2019

Conditions

Breast Cancer

Keywords

Metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • Identification of molecular biomarkers

    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 Outcomes (1)

  • Safety of metastatic biopsies during bevacizumab therapy

    continuous assessment and after inclusion of 10 patients, After completion of the study which will take up to 1 year

Other Outcomes (2)

  • Molecular changes by bevacizumab

    After completion of the study which will take up to 3 years

  • Efficacy of bevacizumab

    After completion of the study, After completion of the study, which will take up to 3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Drug: BevacizumabDrug: Paclitaxel

Arm B

ACTIVE COMPARATOR

Arm B: Paclitaxel 80mg/m2 iv weekly.

Drug: Paclitaxel

Interventions

BevacizumabDRUG

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

Also known as: Avastin
Arm A
PaclitaxelDRUG

80mg/m2 iv weekly

Also known as: Paxene, Taxol
Arm AArm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Written informed consent must be given.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Solna, Stockholm County, 17176, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Theodoros Foukakis, MD PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

  • Jonas Bergh, Professor

    Karolinska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 22, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

SE(1)