ISRCTN79877830
Completed
Phase 2
Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases (CiPHER)
The Clatterbridge Cancer Centre NHS Foundation Trust (UK)0 sites19 target enrollmentJune 20, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases.
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust (UK)
- Enrollment
- 19
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •First or second line metastatic HER2 negative\* breast cancer
- •1\. Oligometastatic brain disease that is unsuitable for surgical resection and/or stereotactic radiosurgery
- •2\. Age 18 years or over
- •3\. ECOG performance status 0\-2
- •4\. Diagnosis of metastatic HER2\-negative breast cancer
- •5\. 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.
- •6\. Females of child bearing potential who have a negative pregnancy test prior to study entry
- •7\. Agree to use adequate contraception which they agree to continue for 12 months after the study treatment
- •8\. Ability and capacity to comply with study and follow\-up procedure
- •9\. Able to provide written informed consent
Exclusion Criteria
- •1\. Received prior radiotherapy/radiosurgery to the brain (radiotherapy may be offered on disease progression)
- •2\. Received \>2 lines of chemotherapy for metastatic recurrent disease (adjuvant treatment is permitted) prior to registration
- •3\. Received any chemotherapy after the diagnosis of brain metastases
- •4\. Previous hormone therapy if it will not be discontinued before Cabazitaxel treatment
- •5\. 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)
- •6\. Visceral metastases with no recorded brain metastases
- •7\. Pregnancy or lactation
- •8\. Prior surgery, radiation, chemotherapy, or other anti\-cancer therapy within 28 days prior to registration
- •9\. Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
- •10\. Grade \=2 peripheral motor and/or sensory neuropathy
Outcomes
Primary Outcomes
Not specified
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