Overview
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.
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.
Eligibility
Inclusion Criteria:
- Written informed consent
- Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease
- Measurable disease as per RECIST 1.1
- HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration<2.0) in the case of IHC 2+
- ECOG performance status 0 or 1
- ER+ve or ER-ve
- Female age ≥18 years
- Anticipated life expectancy > 6 months
- Haemoglobin >10.0g/DL
- Absolute neutrophil count>1.5 x 10^9/L
- Platelet count>100 x 10^9/L
- ALT/SGPT<1.5 X ULN
- Serum creatinine <1.5 x ULN
- Negative pregnancy test for all women of child bearing potential
Exclusion Criteria:
- Grade ≥2 oral mucositis or peripheral or sensory neuropathy
- History of other malignancy
- History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes
- Clinically significant cardiovascular disease
- Any acute or chronic medical condition
- Acute infection requiring systemic antibiotics or antifungal medication
- Sex hormones
- Administration of any live vaccine within 8 weeks
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
- Participation in another clinical trial with an investigational drug within 30 days of randomisation
- Pregnant or breast feeding women
- Contraindications to the use of corticosteroid treatment
- HER2 Positive breast cancer
- Previous Paclitaxel chemotherapy in the adjuvant setting
- Previous cytotoxic chemotherapy for metastatic disease
- Palliative radiotherapy for metastatic disease within 4 weeks of randomisation
- Symptomatic brain metastases confirmed with CT/MRI brain
- History of other malignancy
- Grade 2