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

November 11, 2019 updated by: University Hospitals Bristol and Weston NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Bath, United Kingdom
      • Blackpool, United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre, Horfield Road
        • Contact:
        • Principal Investigator:
          • Amit K Bahl
      • Cardiff, United Kingdom
      • Exeter, United Kingdom
        • Recruiting
        • Royal Devon and Exeter Hospital
        • Contact:
      • London, United Kingdom
      • Newcastle, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Taunton, United Kingdom
      • Truro, United Kingdom
      • Worcester, United Kingdom
        • Recruiting
        • Worcestershire Acute Hospitals NHS Trust
        • Contact:
    • Avon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabazitaxel
6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Drug: Cabazitaxel
3 weekly cyctotoxic chemotherapy
Other Names:
  • Jevtana
Active Comparator: Paclitaxel
6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Drug: Paclitaxel
Weekly cyctotoxic chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit rate
Time Frame: At the completion of 6 cycles of chemotherapy, which is after 18 weeks
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
Time Frame: At completion of 6 cycles of chemotherapy, which is after 18 weeks.
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
Time Frame: Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
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 Frame: Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
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 Frame: Determined by time from randomisation to radiological partial response, usually within the 6 cycles of treatment, therefore wihtin 18 weeks.
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
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
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
Time Frame: Form the date of consent to 30 days after trial treatment has stopped.
CTCAE Version 4.0 graded AEs
Form the date of consent to 30 days after trial treatment has stopped.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Investigators

  • Principal Investigator: Amit K Bahl, University Hospitals Bristol and Weston NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON/2012/4234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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