Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer

Sponsor
Japan Breast Cancer Research Group
Study ID
NCT01989780
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
  • Bevacizumab — DRUG
  • Letrozole — DRUG
  • Anastrozole — DRUG
  • Exemestane — DRUG
  • Fulvestrant — DRUG
  • Goserelin — DRUG
  • leuprorelin — DRUG

Study Details

To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.

Key Dates

First listed
Nov 21, 2013
Start date
Jan 31, 2014
Status verified
Jul 2019
Primary completion
Jun 30, 2018
Completion
Jun 30, 2019

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    weekly paclitaxel + bevacizumab
  • Experimental: Arm B
    endocrine therapy\* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy (\*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)

Primary Outcome Measure

Time to failure of strategy (TFS) [ Time Frame: 2.5 years ]

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