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

Completed

• Conditions: Metastatic; Breast Cancer
• Interventions: Drug: Bevacizumab; Drug: paclitaxel

• Registration Number: NCT01745757
• Lead Sponsor: UNICANCER

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2022-06
• Study Completion: 2022-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Bevacizumab	first line treatment for metastatic breast cancer
Cohort	paclitaxel	first line treatment for metastatic breast cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life assessment	2 years
Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel.	2 years	These biomarkers will be selected from biological studies, proteomics and pharmacogenetics.
The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety.	2 years

Trial Locations

Locations (18)

Hôpital Européen; 🇫🇷 Marseille, France

Centre Hospitalier; 🇫🇷 Roanne, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU Grenoble; 🇫🇷 Grenoble, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Catherine de Sienne; 🇫🇷 Nantes, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Institut Curie; 🇫🇷 Saint Cloud, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre les Nancy, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France