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

Breast Cancer Clinical Trial

— COMET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745757
• Other study ID #: UC-0102/1203 - GRT02
• Secondary ID: 2012-A00244-39GR
• Status: Completed
• Start date: June 2012
• Est. completion date: December 2022

Study information

• Verified date: January 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic

Intervention

Drug:
• Bevacizumab
Treatments received by patients in this study are prescribed in the context of standard care
• paclitaxel
Treatments received by patients in this study are prescribed in the context of standard care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & 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, 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

Outcome

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