Clinical trial NCT01978977: Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
Official title: Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: mBC
HER2 negative
Chemotherapy
Anti-angiogenic agent
Bevacizumab
1st Line
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Clinics for cancer prevention

Brief summary: Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.

Detailed description: Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥18 years
* Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
* No prior first line treatment for metastatic Breast Cancer
* Previous hormonotherapy for metastatic Breast Cancer is allowed
* One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
* ECOG performance status ≤2
* Adequate haematological, renal and hepatic function
* Urine protein \<2+ (dipstick)
* Life expectancy of ≥12 weeks

Exclusion Criteria:

* Previous first line treatment for metastatic colorectal cancer(progression \>12 months after the end of adjuvant treatment)
* Previous radiotherapy to target lesions
* Patients with brain metastases and/or cancerous meningitis
* Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
* Patients participating in interventional clinical trial

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Every 2 or 3 weeks up to 12 or 18 weeks
Secondary outcomes:
measure: Number of Participants with Response Rate
timeFrame: Disease evaluation at Week 3 or at week 6
measure: Percentage of Patients with Progression Free Survival
timeFrame: 1 year
measure: Patients Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: Hellenic Oncology Research Group
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: