Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust; University Hospitals Bristol NHS Foundation Trust
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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