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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Bristol and Weston NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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