Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab and Paclitaxel in Patients With Metastatic Breast Cancer
COMET
3 other identifiers
observational
510
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
19 active sites
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
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 27, 2023
January 1, 2023
10 years
September 18, 2012
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (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
2 years
Secondary Outcomes (3)
Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel.
2 years
Quality of Life assessment
2 years
The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety.
2 years
Study Arms (1)
Cohort
first line treatment for metastatic breast cancer
Interventions
Treatments received by patients in this study are prescribed in the context of standard care
Treatments received by patients in this study are prescribed in the context of standard care
Eligibility Criteria
metastatic breast cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (19)
Institut Bergonie
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges Francois Leclerc
Dijon, France
CHU Grenoble
Grenoble, France
Centre Leon Berard
Lyon, France
Hôpital Européen
Marseille, France
Institut Paoli Calmettes
Marseille, France
Centre Val d'Aurelle
Montpellier, France
Centre Catherine de Sienne
Nantes, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Institut Jean Godinot
Reims, France
Centre Hospitalier
Roanne, France
Institut Curie
Saint-Cloud, France
Centre Paul Strauss
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Related Publications (3)
Bortolini Silveira A, Bidard FC, Tanguy ML, Girard E, Tredan O, Dubot C, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Rios M, Mouret-Reynier MA, Dalenc F, Hego C, Rampanou A, Albaud B, Baulande S, Berger F, Lemonnier J, Renault S, Desmoulins I, Proudhon C, Pierga JY. Multimodal liquid biopsy for early monitoring and outcome prediction of chemotherapy in metastatic breast cancer. NPJ Breast Cancer. 2021 Sep 9;7(1):115. doi: 10.1038/s41523-021-00319-4.
PMID: 34504096RESULTGal J, Milano G, Brest P, Ebran N, Gilhodes J, Llorca L, Dubot C, Romieu G, Desmoulins I, Brain E, Goncalves A, Ferrero JM, Cottu PH, Debled M, Tredan O, Chamorey E, Merlano MC, Lemonnier J, Etienne-Grimaldi MC, Pierga JY. VEGF-Related Germinal Polymorphisms May Identify a Subgroup of Breast Cancer Patients with Favorable Outcome under Bevacizumab-Based Therapy-A Message from COMET, a French Unicancer Multicentric Study. Pharmaceuticals (Basel). 2020 Nov 23;13(11):414. doi: 10.3390/ph13110414.
PMID: 33238394RESULTVasseur A, Cabel L, Tredan O, Chevrier M, Dubot C, Lorgis V, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Luporsi E, Mouret-Reynier MA, Dalenc F, Lemonnier J, Savignoni A, Tanguy ML, Bidard FC, Pierga JY. Prognostic value of CEC count in HER2-negative metastatic breast cancer patients treated with bevacizumab and chemotherapy: a prospective validation study (UCBG COMET). Angiogenesis. 2020 May;23(2):193-202. doi: 10.1007/s10456-019-09697-7. Epub 2019 Nov 26.
PMID: 31773439RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Yves PIERGA, MD, PhD
Institut Curie Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2012
First Posted
December 10, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
January 27, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.