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:Duration of progression free survival

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:Time taken for tumour burden to respond to treatment
Measure: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
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

November 13, 2019