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

Bayer AG0 sites519 target enrollmentJanuary 5, 2011

DrugsNexavar Xeloda

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Bayer AG
Enrollment: 519
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 5, 2011

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bayer AG

Eligibility Criteria

Inclusion Criteria

•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 an accredited laboratory by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), or chromogenic in situ hybridization (CISH). Note: local accreditation is acceptable.
•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 radiologically evaluable) disease (according to RECIST 1\.1\).
•All computer tomography \[CT] \[with contrast] and magnetic resonance imaging \[MRI]) used to document disease must have been done \= 4 weeks before randomization. Bone scans (if clinically indicated) must be done \= 12 weeks prior to randomization.
•Subject must have received up to two prior chemotherapy regimens (adjuvant/neo adjuvant treatments are considered one regimen), and no more than one prior regimen for advanced and/or metastatic disease. Chemotherapy regimens include both targeted and biologic therapy.
•Prior regimens must have included an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel), either in combination or in separate regimens, in either the neo\-adjuvant/adjuvant or the metastatic setting or both, as either monotherapy or as part of a combination with another agent. Sequential regimens will count as a single regimen; multiple neo\-adjuvant / adjuvant regimens will count as a single regimen.
•Subject must meet at least one of the following scenarios to be eligible for the study (see Appendix 14\.19 in the protocol for definitions of treatment resistance and failure):
•\-Resistant to or have failed prior taxane and anthracycline

Exclusion Criteria

•HER2\-positive breast cancer (IHC \= 3\+, positive FISH, or positive CISH); equivocal or unknown HER2 status. Subjects with equivocal HER2 status may consent to having their HER2 status retested prior to enrollment by an accredited laboratory.
•Unknown hormone receptor status (estrogen and progesterone receptor).
•No prior taxane and anthracycline for the treatment of breast cancer (either in adjuvant, neo\-adjuvant or metastatic setting).
•Bilateral breast cancer or a history of two distinct breast cancers are excluded.
•Inflammatory breast carcinoma are excluded.
•Subject must NOT have
•oactive or clinically significant cardiac disease.
•othrombotic, embolic, venous, or arterial events within 6 months before randomization.
•oany hemorrhage/bleeding event of NCI\-CTCAE v4\.0 Grade 3 or above within 4 weeks before randomization.
•Radiation to any lesions \< 4 weeks prior to randomization. Palliative radiation to bone metastasis for pain control is permitted with provisions.