A trial of 3 weekly cabazitaxel versus weekly pactlitaxel for the first treatment of metastatic breast cancer.

• Conditions: Metastatic breast cancer; MedDRA version: 17.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000918-61-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-22
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Written informed consent
Metastatic breast cancer, fit to receive cytotoxic chemotherapy as palliative treatment.
Measurable disease as per RECIST 1.1 by CT or MRI within 4 weeks of registration.
ECOG performance status 0 or 1
No prior cytotoxic chemotherapy for metastatic disease. Neoadjuvant or adjuvant chemotherapy permitted if given more than 3 months prior to registration.
Patients may be taxane naive or have received docetaxel chemotherapy in the adjuvant setting.
Prior histology to confirm HER 2 negative defined as IHC 0+, 1+ or IHC 2+ with FISH/SISH/CISH (Ratio <2.0)in case of IHC 2+
ER+ and ER- Both eligible.
Age = 18
Anticipated life expectancy >6 months.
Adequate liver, renal and bone marrow function defined as:
Haemoglobin >9.0g/dL
Absolute neutrophil count > 1.5 x 10^9/L
Platelet count >100 x 10^9/L
ALT< 2.5 X ULN
Total bilirubin < 1.0 x ULN
Serum creatinine < 1.5 x ULN
Negative pregnancy test bu urine or serum within 7 days prior to randomisation for all women of child bearing potential
Complete staging work up within 4 weeks prior to randomisation.
Patients must be available and compliant for diagnostics, treatment and follow up.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

HER 2 + breast cancer (IHC 3+ or FISH/SISH/CISH ratio 2.0 )
Previous paclitaxel chemotherapy in the adjuvant setting.
Prior cytotoxic chemotherapy for metastatic disease.
Palliative radio therapy for metastatic disease within 4 weeks of randomisation.
Symptomatic brain metastases.
History or other malignancy (excluding non-melanomatous skin cancer).
Grade = 2 peripheral motor +/or sensory neuropathy.
Grade = 2 oral mucositis.
History of severe hypersensitivity reaction (= grade 3) to taxanes.
History of severe hypersensitivity reaction (= grade 3) to polysorbate 80- containing drugs.
Clinically significant (active) cardiovascular disease, including cerebrovascular accident (within 6 months before enrolment), myocardial infarction, arterial thrombotic events within 6 months before enrolment, unstable angina pectoris, New York heart association grade 2 congestive heart failure, serious cardiac arrythmia requiring medication during the study and that might intefere with regularity of the study treatment, or not controlled by medication.
Any severe acute or chronic medical condition which could impair the ability of the patient to participate in the study or comply with the study procedures or interfere with interpretation of study results.( such as significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures.)
Active infection requiring systemic antibiotics or antifungal medication.
Prior endocrine therapy treatment must be stopped before study entry.
Concurrent treatment on another clinical trial.
Requirement for radiation therapy concurrent withthe study.
Inability and unwillingness to comply with study visits, treatment, testing and to comply with the protocol.
Other concurrent serious illness or medical conditions which make it undesirable for the patient to enter the trial including uncontrolled diabetes mellitus.
Inadequate organ and bone marrow function as evidenced by :
Haemoglobin <9.0g/L
Absolute neutrophil count < 1.5 x 10^9
AST>2.5 x ULN
Total bilirubin > 1.5 x ULN
Serum creatinine > 1.5 x ULN. If creatinine is 1.0-1.5 x ULN, creatinine clearnace will be calculated according to CKD-EPI formula and patients with creatinine clearance <60mls/min should be excluded. (See appendix 2 for formula)
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. ( A one week washout period is necessary for patients who are already on these treatments. (Appendix 4)
Participation in another clinical trial with any investigational drug within 30 days prior to randomisation.
Pregnancy or breast feeding women.
Patients with child bearing potential who do not agree to use accepted and effective method of contraception ( barrier method, intrauterine devices, sterilisation) during the study treatment period and for a period of 12 months after the last study drug administration..
Contraindications to the use of corticosteroid treatment.

Grade = 2 peripheral neuropathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified