Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT01120158
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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.
  • Paclitaxel — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 10, 2010
Start date
Sep 30, 2009
Status verified
Feb 2017
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Paclitaxel/Bevacizumab

Primary Outcome Measure

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ]

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