EUCTR2012-000542-35-GB
Active, not recruiting
Phase 1
Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases. - CiPHER
ConditionsHer-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]
DrugsJevtana
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Her-2 negative breast cancer with brain metastases
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Enrollment
- 19
- Status
- Active, not recruiting
- 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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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