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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2023
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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