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About
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor.
Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway.
LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Women with histologically confirmed breast cancer
18 < age < 80 years old
Menopausal status Women are considered post-menopausal and not of child bearing potential if they have had
ER-positive status by local laboratory testing (>10% by IHC) and HER2-negative status (IHC 0 or 1+ or 2+ and FISH negative) on the last biopsy or surgical specimen available.
Disease progression defined as inoperable locally advanced or metastatic breast cancer (MBC) excluding aggressive visceral disease requiring other approaches, such as chemotherapy
Disease refractory to aromatase inhibitors (AI) defined as:
Patients who have received fulvestrant are eligible
Maximum 2 previous lines of chemotherapy for MBC
Performance Status (PS) ≤ 2
Patient able to swallow and retain oral medication
Measurable or evaluable lesions as per RECIST 1.1
Adequate bone marrow and organ function as defined by the following laboratory values:
Patient has signed informed consents obtained before any trial related activities and according to local guidelines
Exclusion criteria
• Previous treatment with p38 MAPK inhibitors or Tamoxifen in metastatic setting (adjuvant treatment by tamoxifen is allowed)
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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