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Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer (CONCEPT)

Primary Purpose

HER2 Negative Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cabazitaxel
Paclitaxel
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Negative Metastatic Breast Cancer focused on measuring Breast cancer, HER2 negative, Cabazitaxel, Paclitaxel, Chemotherapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial Healthcare NHS TrustRecruiting
  • Royal United HospitalRecruiting
  • Blackpool Victoria HospitalRecruiting
  • Bristol Haematology and Oncology Centre, Horfield RoadRecruiting
  • Velindre Cancer CentreRecruiting
  • Royal Devon and Exeter HospitalRecruiting
  • Guy's HospitalRecruiting
  • Freeman HospitalRecruiting
  • City Hospital, NottinghamRecruiting
  • Derriford HospitalRecruiting
  • Musgrove Park HospitalRecruiting
  • Royal Cornwall and TreliskeRecruiting
  • Worcestershire Acute Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cabazitaxel

Paclitaxel

Arm Description

6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle

6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.

Outcomes

Primary Outcome Measures

Progression free survival
Duration of progression free survival

Secondary Outcome Measures

Clinical benefit rate
Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria
Objective response rate
Defined as complete and partial response recorded from the start of treatment to completion of 6 cycles of treatment.
Overall survival
Survival duration from randomisation to date of death.
Time to next chemotherapy treatment
time from randomisation to another chemotherapy treatment after confirmed progression.
Time to response
Time taken for tumour burden to respond to treatment
Quality of life as measured by patients themselves
2 Quality of life questionnaires
Number of adverse events and Number of participants with adverse events per arm and the grade of AEs
CTCAE Version 4.0 graded AEs

Full Information

First Posted
October 30, 2014
Last Updated
November 11, 2019
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03048942
Brief Title
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Negative Metastatic Breast Cancer
Keywords
Breast cancer, HER2 negative, Cabazitaxel, Paclitaxel, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Other Intervention Name(s)
Jevtana
Intervention Description
3 weekly cyctotoxic chemotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Weekly cyctotoxic chemotherapy
Primary Outcome Measure Information:
Title
Progression free survival
Description
Duration of progression free survival
Time Frame
Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Secondary Outcome Measure Information:
Title
Clinical benefit rate
Description
Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria
Time Frame
At the completion of 6 cycles of chemotherapy, which is after 18 weeks
Title
Objective response rate
Description
Defined as complete and partial response recorded from the start of treatment to completion of 6 cycles of treatment.
Time Frame
At completion of 6 cycles of chemotherapy, which is after 18 weeks.
Title
Overall survival
Description
Survival duration from randomisation to date of death.
Time Frame
Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
Title
Time to next chemotherapy treatment
Description
time from randomisation to another chemotherapy treatment after confirmed progression.
Time Frame
Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
Title
Time to response
Description
Time taken for tumour burden to respond to treatment
Time Frame
Determined by time from randomisation to radiological partial response, usually within the 6 cycles of treatment, therefore wihtin 18 weeks.
Title
Quality of life as measured by patients themselves
Description
2 Quality of life questionnaires
Time Frame
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
Title
Number of adverse events and Number of participants with adverse events per arm and the grade of AEs
Description
CTCAE Version 4.0 graded AEs
Time Frame
Form the date of consent to 30 days after trial treatment has stopped.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit K Bahl
Phone
0117 342 2418
Email
amit.bahl@uhbristol.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Bravo
Email
alicia.bravo@uhbristol.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit K Bahl
Organizational Affiliation
University Hospitals Bristol and Weston NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial Healthcare NHS Trust
City
London
State/Province
Avon
ZIP/Postal Code
bs3 1ta
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shola Ogegbo
Email
shola.ogegbo@imperial.nhs.uk
Facility Name
Royal United Hospital
City
Bath
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Allen
Email
tania.allen1@nhs.net
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Thornborough
Email
lauren.thornborough@nhs.net
Facility Name
Bristol Haematology and Oncology Centre, Horfield Road
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Markham
Phone
0117 342 6736
Email
alison.markham@uhbristol.nhs.uk
First Name & Middle Initial & Last Name & Degree
Amit K Bahl
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Boobier
Email
Clare.Boobier@wales.nhs.uk
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizzy Baines
Phone
01932 402865
Email
kizzy.baines@nhs.net
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Bayliss
Email
Chris.Bayliss@gstt.nhs.uk
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Blackwell
Email
Lucy.Blackwell@nuth.nhs.uk
Facility Name
City Hospital, Nottingham
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Tasker
Email
carol.tasker@nuh.nhs.uk
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
helen smith
Email
helensmith23@nhs.net
Facility Name
Musgrove Park Hospital
City
Taunton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Locke
Email
Angela.Locke@tst.nhs.uk
Facility Name
Royal Cornwall and Treliske
City
Truro
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Goddard
Email
caroline.goddard@nhs.net
Facility Name
Worcestershire Acute Hospitals NHS Trust
City
Worcester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayne tyler
Email
jaynetyler@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

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