NCT03048942

Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

Detailed description

This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.

Conditions

• HER2 Negative Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	3 weekly cyctotoxic chemotherapy
DRUG	Paclitaxel	Weekly cyctotoxic chemotherapy

Timeline

• Start date: 2014-11-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2017-02-09
• Last updated: 2019-11-13

Locations

13 sites across 1 country: United Kingdom