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.
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
| Drug | Synonyms | Arms |
|---|
| Cabazitaxel | Jevtana | Cabazitaxel |
| Paclitaxel | | Paclitaxel |
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
| Name | Type | Description | Interventions |
|---|
| Cabazitaxel | Experimental | 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle | |
| Paclitaxel | Active Comparator | 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle. | |
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 and Weston NHS Foundation Trust |
Trial Keywords
- Breast cancer
- HER2 negative
- Cabazitaxel
- Paclitaxel
- Chemotherapy
Last Updated
November 13, 2019
