Clinical Trials /

Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

NCT03048942

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
  • 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 IDs

  • ORG STUDY ID: ON/2012/4234
  • NCT ID: NCT03048942

Conditions

  • HER2 Negative Metastatic Breast Cancer

Interventions

DrugSynonymsArms
CabazitaxelJevtanaCabazitaxel
PaclitaxelPaclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CabazitaxelExperimental6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
  • Cabazitaxel
    PaclitaxelActive Comparator6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
      • Paclitaxel

    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

    Maximum Eligible Age:99 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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.
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Clinical benefit rate
    Time Frame:At the completion of 6 cycles of chemotherapy, which is after 18 weeks
    Safety Issue:
    Description:Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria
    Measure:Objective response rate
    Time Frame:At completion of 6 cycles of chemotherapy, which is after 18 weeks.
    Safety Issue:
    Description:Defined as complete and partial response recorded from the start of treatment to completion of 6 cycles of treatment.
    Measure: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.
    Safety Issue:
    Description:Survival duration from randomisation to date of death.
    Measure: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.
    Safety Issue:
    Description:time from randomisation to another chemotherapy treatment after confirmed progression.
    Measure: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.
    Safety Issue:
    Description:
    Measure:Quality of life
    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
    Safety Issue:
    Description:2 Quality of life questionnaires
    Measure: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.
    Safety Issue:
    Description:CTCAE Version 4.0 graded AEs

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University Hospitals Bristol NHS Foundation Trust

    Trial Keywords

    • Breast cancer
    • HER2 negative
    • Cabazitaxel
    • Paclitaxel
    • Chemotherapy

    Last Updated

    February 6, 2017