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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01745757
First received: September 18, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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, EMEA 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 MBC 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 Intervention
Metastatic
Breast Cancer
Drug: Bevacizumab
Drug: paclitaxel

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    These biomarkers will be selected from biological studies, proteomics and pharmacogenetics.

  • Quality of Life assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 510
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cancer metastatic breast cancer

Criteria

Inclusion Criteria:

  • Male or female age (e) of 18 or more.
  • 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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745757

Contacts
Contact: Jerome LEMONNIER, PhD +33 1 7193 6702 j-lemonnier@unicancer.fr

Locations
France
Institut Bergonie Recruiting
Bordeaux, France
Centre Francois Baclesse Recruiting
Caen, France
Centre Jean Perrin Recruiting
Clermont Ferrand, France
Centre Georges Francois Leclerc Recruiting
Dijon, France
CHU Grenoble Active, not recruiting
Grenoble, France
Centre Leon Berard Recruiting
Lyon, France
Hôpital Européen Active, not recruiting
Marseille, France
Institut Paoli Calmettes Recruiting
Marseille, France
Centre Val d'Aurelle Recruiting
Montpellier, France
Centre Catherine de Sienne Active, not recruiting
Nantes, France
Centre Antoine Lacassagne Recruiting
Nice, France
Institut Curie Recruiting
Paris, France
Institut Jean Godinot Recruiting
Reims, France
Centre Hospitalier Active, not recruiting
Roanne, France
Institut Curie Recruiting
Saint Cloud, France
Centre Paul Strauss Not yet recruiting
Strasbourg, France
Institut Claudius Regaud Recruiting
Toulouse, France
Centre Alexis Vautrin Recruiting
Vandoeuvre les Nancy, France
Institut Gustave Roussy Not yet recruiting
Villejuif, France
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Jean-Yves PIERGA, MD, PhD Institut Curie, Paris
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01745757     History of Changes
Other Study ID Numbers: UC-0102/1203 - GRT02, 2012-A00244-39, GRT02
Study First Received: September 18, 2012
Last Updated: August 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014