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

NCT ID: NCT01745757

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2022-12-31

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.

Conditions

Metastatic; Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

first line treatment for metastatic breast cancer

Bevacizumab

Intervention Type: DRUG

Treatments received by patients in this study are prescribed in the context of standard care

paclitaxel

Intervention Type: DRUG

Treatments received by patients in this study are prescribed in the context of standard care

Interventions

Bevacizumab

Treatments received by patients in this study are prescribed in the context of standard care

Intervention Type: DRUG

paclitaxel

Treatments received by patients in this study are prescribed in the context of standard care

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Yves PIERGA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Paris

Locations

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

Countries

France

References

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.

Reference Type: RESULT

PMID: 34504096 (View on PubMed)

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 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.

Reference Type: RESULT

PMID: 33238394 (View on PubMed)

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 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.

Reference Type: RESULT

PMID: 31773439 (View on PubMed)

Other Identifiers

2012-A00244-39

Identifier Type: REGISTRY

Identifier Source: secondary_id

GRT02

Identifier Type: OTHER

Identifier Source: secondary_id

UC-0102/1203 - GRT02

Identifier Type: -

Identifier Source: org_study_id