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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental | 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle |
|
| Paclitaxel | Active Comparator | 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug | 3 weekly cyctotoxic chemotherapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate | Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria | At the completion of 6 cycles of chemotherapy, which is after 18 weeks |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit K Bahl | Contact | 0117 342 2418 | amit.bahl@uhbristol.nhs.uk | |
| Alicia Bravo | Contact | alicia.bravo@uhbristol.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Amit K Bahl | University Hospitals Bristol and Weston NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Healthcare NHS Trust | Recruiting | London | Avon | bs3 1ta | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2026 | |
| Reset | Apr 28, 2026 | |
| Release | May 1, 2026 |
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| Paclitaxel | Drug | Weekly cyctotoxic chemotherapy |
|
Defined as complete and partial response recorded from the start of treatment to completion of 6 cycles of treatment.
| At completion of 6 cycles of chemotherapy, which is after 18 weeks. |
| Overall survival | Survival duration from randomisation to date of death. | 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 | time from randomisation to another chemotherapy treatment after confirmed progression. | 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 | Time taken for tumour burden to respond to treatment | Determined by time from randomisation to radiological partial response, usually within the 6 cycles of treatment, therefore wihtin 18 weeks. |
| Quality of life as measured by patients themselves | 2 Quality of life questionnaires | EQ5D-5L and FACT B will be completed at baseline, prior to cycles 3 and 5 and at the end of treatment visit, therefore within approximately 21 weeks from randomisation |
| Number of adverse events and Number of participants with adverse events per arm and the grade of AEs | CTCAE Version 4.0 graded AEs | Form the date of consent to 30 days after trial treatment has stopped. |
| Royal United Hospital | Recruiting | Bath | United Kingdom |
|
| Blackpool Victoria Hospital | Recruiting | Blackpool | United Kingdom |
|
| Bristol Haematology and Oncology Centre, Horfield Road | Recruiting | Bristol | BS2 8ED | United Kingdom |
|
| Velindre Cancer Centre | Recruiting | Cardiff | United Kingdom |
|
| Royal Devon and Exeter Hospital | Recruiting | Exeter | United Kingdom |
|
| Guy's Hospital | Recruiting | London | United Kingdom |
|
| Freeman Hospital | Recruiting | Newcastle | United Kingdom |
|
| City Hospital, Nottingham | Recruiting | Nottingham | United Kingdom |
|
| Derriford Hospital | Recruiting | Plymouth | United Kingdom |
|
| Musgrove Park Hospital | Recruiting | Taunton | United Kingdom |
|
| Royal Cornwall and Treliske | Recruiting | Truro | United Kingdom |
|
| Worcestershire Acute Hospitals NHS Trust | Recruiting | Worcester | United Kingdom |
|
| Reset | May 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2026 | Apr 28, 2026 | |||
| May 1, 2026 | May 28, 2026 | |||
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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