Breast Cancer Clinical Trial
— COMETOfficial 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
Verified date | January 2023 |
Source | UNICANCER |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 510 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 | Vandoeuvre les Nancy | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
UNICANCER |
France,
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, Desm — View Citation
Gal 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 Polymorphi — View Citation
Vasseur 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel. | These biomarkers will be selected from biological studies, proteomics and pharmacogenetics. | 2 years | |
Secondary | Quality of Life assessment | 2 years | ||
Secondary | The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety. | 2 years |
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