Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 23, 2025
  • participants needed
    160
  • sponsor
    University Hospitals Bristol NHS Foundation Trust
Updated on 23 January 2021

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.

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.

Details
Condition HER2 Negative Metastatic Breast Cancer
Treatment Paclitaxel, Cabazitaxel
Clinical Study IdentifierNCT03048942
SponsorUniversity Hospitals Bristol NHS Foundation Trust
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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