Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

Launched by UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST · Feb 6, 2017

Keywords

ClinConnect Summary

This clinical trial is testing two different chemotherapy drugs, Cabazitaxel and Paclitaxel, to see which one helps women with HER2 negative metastatic breast cancer live longer without their cancer getting worse. The study will include 90 women who will be randomly assigned to receive either Cabazitaxel or Paclitaxel for 18 weeks. If the results show a clear benefit from one of the treatments, the researchers plan to include 70 more patients in the study for further evaluation.

To participate in this trial, women must be at least 18 years old and have been diagnosed with HER2 negative metastatic breast cancer that is measurable and suitable for chemotherapy. They should also be in reasonably good health, with a life expectancy of over six months. Participants can expect to receive regular treatments and will be monitored closely throughout the study. It's important to note that women who are pregnant, breastfeeding, or have certain health conditions may not be eligible to take part in the trial.

Gender

FEMALE

Eligibility criteria

• 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