Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01120158
First received: May 5, 2010
Last updated: June 21, 2014
Last verified: June 2014

May 5, 2010
June 21, 2014
September 2009
December 2014   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01120158 on ClinicalTrials.gov Archive Site
  • Toxicity profile [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer
Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.

Elderly individuals make up a large part of the breast cancer population. Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Bevacizumab
    Bevacizumab (IV) 10 mg/kg on day 1 and day 15. Treatment repeats every 28 days. Therapy will continue until maximum response, disease progression or unacceptable toxicity.
    Other Name: Avastin
  • Drug: Paclitaxel
    Paclitaxel (IV) 120 mg/m2,on day 1 and day 15. Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.
    Other Names:
    • Taxoprol
    • Paxene
    • Taxol
    • Ovapac
Experimental: 1
Paclitaxel/Bevacizumab
Interventions:
  • Drug: Bevacizumab
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast adenocarcinoma
  • No previous therapy (other than hormonal therapy) for metastatic disease is accepted
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
  • adequate renal function (serum creatinine <1.5 times the upper normal limit)
  • bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

Exclusion Criteria:

  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • History of stroke
  • Anticoagulation therapy (except of low dose aspirin <325mg)
  • Other invasive malignancy except non-melanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women
Female
18 Years and older
No
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Greece
 
NCT01120158
CT/08.31
No
Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
Hellenic Oncology Research Group
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP