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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03048942
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
University Hospitals Bristol and Weston NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
HER2 Negative Metastatic Breast Cancer Drug: Cabazitaxel Drug: Paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03048942

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Contact: Amit K Bahl 0117 342 2418
Contact: Alicia Bravo

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United Kingdom
Imperial Healthcare NHS Trust Recruiting
London, Avon, United Kingdom, bs3 1ta
Contact: Shola Ogegbo   
Royal United Hospital Recruiting
Bath, United Kingdom
Contact: Tania Allen   
Blackpool Victoria Hospital Recruiting
Blackpool, United Kingdom
Contact: Lauren Thornborough   
Bristol Haematology and Oncology Centre, Horfield Road Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Alison Markham    0117 342 6736   
Principal Investigator: Amit K Bahl         
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom
Contact: Clare Boobier   
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Contact: Kizzy Baines    01932 402865   
Guy's Hospital Recruiting
London, United Kingdom
Contact: Chris Bayliss   
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Lucy Blackwell   
City Hospital, Nottingham Recruiting
Nottingham, United Kingdom
Contact: Carol Tasker   
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: helen smith   
Musgrove Park Hospital Recruiting
Taunton, United Kingdom
Contact: Angela Locke   
Royal Cornwall and Treliske Recruiting
Truro, United Kingdom
Contact: Carol Goddard   
Worcestershire Acute Hospitals NHS Trust Recruiting
Worcester, United Kingdom
Contact: Jayne tyler   
Sponsors and Collaborators
University Hospitals Bristol and Weston NHS Foundation Trust
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Principal Investigator: Amit K Bahl University Hospitals Bristol and Weston NHS Foundation Trust
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Responsible Party: University Hospitals Bristol and Weston NHS Foundation Trust Identifier: NCT03048942    
Other Study ID Numbers: ON/2012/4234
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospitals Bristol and Weston NHS Foundation Trust:
Breast cancer
HER2 negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action