Study assessing if a chemotherapy drug called Cabazitaxel is effective in Patients with certain type of breast cancer (HER2 negative) that has spread to brain that is un treatable.
- Conditions
- Her-2 negative breast cancer with brain metastasesMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000542-35-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19
• First or second line metastatic HER2 negative* breast cancer
•Oligometastatic brain disease that is unsuitable for surgical resection and/or stereotactic radiosurgery
•Age =18 years
•ECOG performance status 0-2
•Diagnosis of metastatic HER2-negative breast cancer
•At least one measurable target lesion (RECIST 1.0) in the brain (unsuitable for resection) identified by CT scan or MRI within 21 days of registration.
•Females of child bearing potential who have a negative pregnancy test prior to study entry
•Agree to use adequate contraception which they agree to continue for 12 months after the study treatment
•Ability and capacity to comply with study and follow-up procedure
•Able to provide written informed consent
Patients with ER+ve or ER-ve disease are eligible for the study
Patients with meningeal disease are eligible provided they fit the other criteria. Extracranial disease is not a requirement of this study.
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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
•Received prior radiotherapy/radiosurgery to the brain (radiotherapy may be offered on disease progression)
•Received >2 lines of chemotherapy for metastatic recurrent disease (adjuvant treatment is permitted) prior to registration
•Received any chemotherapy after the diagnosis of brain metastases
•Previous hormone therapy if it will not be discontinued before Cabazitaxel treatment
•Patients who have received an increasing dose of steroids to control CNS symptoms within 14 days of registration (steroid use is permitted only when patient is stable at a specific dose at the time of screening)
•Visceral metastases with no recorded brain metastases
•Pregnancy or lactation
•Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 28 days prior to registration
•Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
•Grade =2 peripheral motor and/or sensory neuropathy
•Grade =2 mucositis oral
•History of severe hypersensitivity reaction (=grade 3) to taxanes
•History of severe hypersensitivity reaction (=grade 3) to polysorbate 80-containing drugs
•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:
g.Haemoglobin < 9.0 g/dL
h.Absolute neutrophil count < 1.5 x 109/L,
i.Platelet count <100 x 109/L,
j.AST/SGOT and/or ALT/SGPT >2.5 x ULN;
k.total bilirubin >1.0 x ULN,
l.Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (18). See Appendix B
•Active infection requiring systemic antibiotic or anti – fungal medication.
•Participation in another clinical trial with any investigational drug within 30 days prior to registration
•Administration of potent inhibitors and inducers of P450 3A4/5 enzymes within 7 days of registration, or planned concurrent administration whilst on study. This excludes steroid treatment which is standard care treatment for patients with brain metastases
• Concomitant vaccination with live attenuated vaccines
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method