Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab and Paclitaxel in Patients With Metastatic Breast Cancer (COMET)

January 25, 2023 updated by: UNICANCER

Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer

Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.

The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.

The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • Centre Francois Baclesse
      • Clermont Ferrand, France
        • Centre Jean Perrin
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Grenoble, France
        • CHU Grenoble
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • Hopital Europeen
      • Montpellier, France
        • Centre Val d'Aurelle
      • Nantes, France
        • Centre Catherine de Sienne
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Institut Curie
      • Reims, France
        • Institut Jean Godinot
      • Roanne, France
        • Centre Hospitalier
      • Saint Cloud, France
        • Institut Curie
      • Strasbourg, France
        • Centre Paul Strauss
      • Toulouse, France
        • Institut Claudius Regaud
      • Vandoeuvre les Nancy, France
        • Centre Alexis Vautrin
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

metastatic breast cancer

Description

Inclusion Criteria:

  • Male or female ≥18 years old.
  • Histologically confirmed breast adenocarcinoma, metastatic (measurable or unmeasurable lesion), HER2 negative (on the last tumor tissue analyzed), Patient to receive first-line chemotherapy paclitaxel and bevacizumab in a weekly manner as recommended by the EMEA.
  • Hormone receptor status known
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy ≥12 weeks.
  • Women of childbearing age (except amenorrhea of at least 24 months) must have a negative pregnancy test serum within 28 days before starting treatment. In the absence of serum test, a urine pregnancy test (within 7 days before the first dose of bevacizumab) is required.
  • Informed consent form duly signed and dated by patient

Exclusion Criteria:

  • Prior chemotherapy for metastatic disease ;
  • Concomitant hormone therapy
  • The patient must not have undergone radiation therapy for the treatment of metastatic disease (except cases of analgesic radiotherapy for bone pain due to metastases).
  • Pregnant or nursing woman or woman of childbearing age (except amenorrhea for at least 24 months) who does not use an effective nonhormonal contraceptive method (intrauterine device, barrier method associated with the use of a spermicidal gel or surgical castration) for the duration of the study and 6 months after paclitaxel administration and / or bevacizumab.
  • Man who does not accept to use effective contraception during the study period and 6 months after paclitaxel administration and / or bevacizumab.
  • Known hypersensitivity to paclitaxel and / or to bevacizumab or to any excipients.
  • Patient unable to undergo medical test for geographical, social or psychological reasons.
  • Patient deprived of liberty or placed under the authority of a tutor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
first line treatment for metastatic breast cancer
Drug: Bevacizumab
Treatments received by patients in this study are prescribed in the context of standard care
Drug: paclitaxel
Treatments received by patients in this study are prescribed in the context of standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of the initial rates and changes in CEC / CLC (Biological study) and measure of the visceral fat (imaging study) as predictors of progression-free survival (PFS) and response to bevacizumab and paclitaxel
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel.
Time Frame: 2 years
These biomarkers will be selected from biological studies, proteomics and pharmacogenetics.
2 years
Quality of Life assessment
Time Frame: 2 years
2 years
The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Jean-Yves PIERGA, MD, PhD, Institut Curie Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0102/1203 - GRT02
  • 2012-A00244-39 (Registry Identifier: ID RCB)
  • GRT02 (Other Identifier: UNICANCER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

IPD Sharing Time Frame

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Access Criteria

Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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