Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978977
• Other study ID #: CT/10.17
• Status: Completed
• Phase: N/A
• First received: November 3, 2013
• Last updated: October 6, 2015
• Start date: July 2011
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks	Every 2 or 3 weeks up to 12 or 18 weeks	Yes
Secondary	Number of Participants with Response Rate	In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks	Disease evaluation at Week 3 or at week 6	No
Secondary	Percentage of Patients with Progression Free Survival		1 year	No
Secondary	Patients Overall Survival		1 year	No