Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

HER2 Negative Metastatic Breast Cancer Clinical Trial

— CONCEPT  

Official title:

A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048942
• Other study ID #: ON/2012/4234
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: August 2025

Study information

• Verified date: May 2019
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: Amit K Bahl
• Phone: 0117 342 2418
• Email: amit.bahl[@]uhbristol.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Negative Metastatic Breast Cancer

Intervention

Drug:
• Cabazitaxel
3 weekly cyctotoxic chemotherapy
• Paclitaxel
Weekly cyctotoxic chemotherapy

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital	Bath
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Bristol Haematology and Oncology Centre, Horfield Road	Bristol
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Guy's Hospital	London
United Kingdom	Imperial Healthcare NHS Trust	London	Avon
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Objective response rate	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.