Spots Global Cancer Trial Database for Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

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Trial Identification

Brief Title: Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

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

Study ID: NCT03048942

Conditions

HER2 Negative Metastatic Breast Cancer

Interventions

Cabazitaxel

Paclitaxel

Study Description

Brief 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.