COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745757
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : November 5, 2019
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Drug: Bevacizumab Drug: paclitaxel

Layout table for study information
Study Type : Observational
Actual Enrollment : 510 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. Quality of Life assessment [ Time Frame: 2 years ]
  3. The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety. [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic breast cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745757

Show Show 19 study locations
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Jean-Yves PIERGA, MD, PhD Institut Curie Paris
Layout table for additonal information
Responsible Party: UNICANCER Identifier: NCT01745757    
Other Study ID Numbers: UC-0102/1203 - GRT02
2012-A00244-39 ( Registry Identifier: ID RCB )
GRT02 ( Other Identifier: UNICANCER )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors