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Weekly oral vinorelbine versus weekly paclitaxel as first-line monotherapy in ER-positive, HER2-negative advanced breast cancer
2012-003530-16Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2012
- Countries
- 1
- Sponsor
- Pierre Fabre Laboratories
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial in breast cancer comparing Weekly oral vinorelbine with Weekly paclitaxel (2 arms). Primary endpoint: Disease control rate. Started Nov 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Weekly oral vinorelbine
First-line weekly oral vinorelbine monotherapy.
Weekly paclitaxel
First-line weekly paclitaxel monotherapy.
03
Who it enrols
Adult women with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer eligible for first-line chemotherapy.
04
Endpoints
Primary
Disease control rate
Secondary
Response rate
Duration of response
Duration of stable disease
Progression-free survival
Time-to-treatment failure
Overall survival
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