A Phase III Randomized, Double blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer - Resilience
- Conditions
- ocally advanced or metastatic HER2-negative breast cancer.MedDRA version: 9.1 Level: LLT Classification code 10004244
- Registration Number
- EUCTR2010-018501-10-IT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 537
• Age is =18 years. • Life expectancy is at least 12 weeks (3 months). • Subject has histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast. HER2 status should be determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), or chromogenic in situ hybridization (CISH). If the subject’s HER2 status was determined using a test kit that is not approved by an appropriate regulatory authority (eg, US Food and Drug Administration) and/or was not tested using a validated assay, HER2 status will be confirmed, with the subject’s consent, using an approved test kit and/or validated assay. If such a subject does not consent to re-testing, the subject will not be eligible for the study. •Subject has locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent (Stage IIIb or IIIc; American Joint Committee on Cancer [AJCC] Staging System, Sixth Edition). •Subject has measurable or non-measurable (but clinically evaluable) disease (according to RECIST 1.1). •All scans used to document disease were done = 4 weeks before randomization. •Subjects are resistant to or have failed a taxane and an anthracycline or for whom further anthracycline therapy is not indicated. oPrior treatment must have included both a taxane (eg, paclitaxel or docetaxel) and an anthracycline (eg, doxorubicin or epirubicin). oThese agents may have been given as either monotherapy or as part of a combination with another agent and may have been included in the same regimen. oSequential neo-adjuvant or adjuvant regimens will count as a single regimen. oThese agents may have been given in either the neo-adjuvant/adjuvant or the metastatic setting or both. oResistance is defined as: -tumor progression while on taxane or within 4 months of last taxane dose when given in the metastatic setting OR •tumor progression while on anthracycline or within 3 months of last anthracycline dose when given in the metastatic setting OR -recurrence within 12 months of the last taxane or anthracycline dose when given in the adjuvant or neo-adjuvant setting. oSubjects for whom further anthracycline is not indicated; such subjects must have received cumulative doses of 400 mg/m2 to 550 mg/m2 of doxorubicin or doxorubicin equivalents (eg, epirubicin). oNote: Subject must meet at least one of the following scenarios to be eligible for the study: -Resistant to or have failed prior taxane and anthracycline (as defined above). -Resistant to or have failed prior taxane and for whom further anthracycline therapy is not indicated (as defined above). •Subject must have received no more than one chemotherapy regimen for metastatic disease. oSubject must have received prior taxane and an anthracycline in the neo-adjuvant/adjuvant setting or metastatic setting. •Prior hormonal therapy for locally advanced or metastatic breast cancer is allowed. •Prior neo-adjuvant or adjuvant chemotherapy is allowed. •Subject must have discontinued prior chemotherapy, prior radiation therapy, or prior hormonal therapy for locally advanced or metastatic disease for greater than or equal to 4 weeks before randomization. Previously radiated areas must not be the only site of disease. •Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. •Creatinine clearance greater than or equal to 50 ml/min (based on Cockcroft-Gault formula).
Are the trial subjects under 18?
• Subject must NOT have o active or clinically significant cardiac disease. o thrombotic, embolic, venous, or arterial events within 6 months before randomization. o pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or above within 4 weeks before randomization. o any other hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or above within 4 weeks before randomization.
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