Comparing two chemotherapy drugs for HER2 negative breast cancer
A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer
This study is testing whether Cabazitaxel or Paclitaxel works better as the first treatment for people with HER2 negative metastatic breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Hospitals Bristol and Weston NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (London, Avon and 12 other locations) |
| Trial ID | NCT03048942 on ClinicalTrials.gov |
What this trial studies
This pilot study involves 90 patients with HER2 negative metastatic breast cancer who will be randomly assigned to receive either Cabazitaxel or Paclitaxel as their first line chemotherapy treatment. The study aims to evaluate the efficacy and safety of these two drugs over 18 weeks, focusing on progression-free survival. If initial results indicate a potential benefit, the study may expand to include an additional 70 patients. The randomization will occur in a 1:1 ratio between the two treatment groups.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with HER2 negative metastatic breast cancer who are fit for cytotoxic chemotherapy.
Not a fit: Patients with grade 2 or higher oral mucositis or neuropathy, or those with significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into effective chemotherapy options for patients with HER2 negative breast cancer.
How similar studies have performed: Other studies have explored chemotherapy options for breast cancer, but this specific comparison of Cabazitaxel and Paclitaxel in HER2 negative cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, Avon and 12 other locations
- Imperial Healthcare NHS Trust — London, Avon, United Kingdom (Recruiting)
- Royal United Hospital — Bath, United Kingdom (Recruiting)
- Blackpool Victoria Hospital — Blackpool, United Kingdom (Recruiting)
- Bristol Haematology and Oncology Centre, Horfield Road — Bristol, United Kingdom (Recruiting)
- Velindre Cancer Centre — Cardiff, United Kingdom (Recruiting)
- Royal Devon and Exeter Hospital — Exeter, United Kingdom (Recruiting)
- Guy's Hospital — London, United Kingdom (Recruiting)
- Freeman Hospital — Newcastle, United Kingdom (Recruiting)
- City Hospital, Nottingham — Nottingham, United Kingdom (Recruiting)
- Derriford Hospital — Plymouth, United Kingdom (Recruiting)
- Musgrove Park Hospital — Taunton, United Kingdom (Recruiting)
- Royal Cornwall and Treliske — Truro, United Kingdom (Recruiting)
- Worcestershire Acute Hospitals NHS Trust — Worcester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Amit K Bahl — University Hospitals Bristol and Weston NHS Foundation Trust
- Study coordinator: Amit K Bahl
- Email: amit.bahl@uhbristol.nhs.uk
- Phone: 0117 342 2418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.