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Completed

NCT Number: NCT01745757

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonie, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

paclitaxel

Drug

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

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel.

    Time frame: 2 years

    These biomarkers will be selected from biological studies, proteomics and pharmacogenetics.

  2. Quality of Life assessment

    Time frame: 2 years

  3. The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study 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

Acronym: COMET

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2012
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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