Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
CONCEPT
A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer
1 other identifier
interventional
158
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedStudy Start
First participant enrolled
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2025
CompletedResults Posted
Study results publicly available
July 21, 2026
CompletedJuly 21, 2026
March 1, 2026
6.4 years
October 30, 2014
April 8, 2026
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Duration of progression free survival
Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Secondary Outcomes (8)
Clinical Benefit Rate
At the completion of 6 cycles of chemotherapy, which is after 18 weeks
Objective Response Rate
At completion of 6 cycles of chemotherapy, which is after 18 weeks.
Overall Survival
Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
Time to Next Chemotherapy Treatment
Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
Time to Response
Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.
- +3 more secondary outcomes
Study Arms (2)
Cabazitaxel
EXPERIMENTAL6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Paclitaxel
ACTIVE COMPARATOR6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Royal United Hospital
Bath, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Bristol Haematology and Oncology Centre, Horfield Road
Bristol, BS2 8ED, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Imperial Healthcare NHS Trust
London, W6 8RF, United Kingdom
Guy's Hospital
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
City Hospital, Nottingham
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Royal Cornwall and Treliske
Truro, United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Amit Bahl
- Organization
- University Hospitals Bristol and Weston NHS Foundation Trust
Study Officials
- PRINCIPAL INVESTIGATOR
Amit K Bahl
University Hospitals Bristol and Weston NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
February 9, 2017
Study Start
December 18, 2014
Primary Completion
April 26, 2021
Study Completion
March 19, 2025
Last Updated
July 21, 2026
Results First Posted
July 21, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share