Clinical Trial Details
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NCT02322853 : A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g.,
age appropriate, history of vasomotor symptoms) or

- 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and
estradiol < 20 pg/mL or

- surgical bilateral oophorectomy (with or without hysterectomy) at least six
weeks ago. In the case of oophorectomy alone, only when the reproductive status
of the woman has been confirmed by follow up hormone level assessment is she
considered not of child bearing potential

- 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

- 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:

- recurrence while on, or within 12 months of end of adjuvant treatment with
aromatase inhibitor, or

- progression while on, or within 3 months of end of AI for locally advanced or

- 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

- Measurable disease (? 20 mm by conventional techniques or ? 10 mm by spiral
computed tomography scan) or

- Non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of
measurable disease.

- Patients with only pleural effusion and/or ascites are not eligible.

- Adequate bone marrow and organ function as defined by the following laboratory

- Absolute Neutrophil Count (ANC) ? 1.0 x 109/L

- Platelets (plt) ? 100 x 109/L

- Hemoglobin (Hgb) ? 9 g/dl

- INR ? 1.5 without any anticoagulation treatment

- Serum creatinine ? 1.5 x ULN

- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) within
normal range (or < 3.0 x ULN if liver metastases are present)

- Total serum bilirubin within normal range (or ? 1.5 x ULN if liver metastases
are present; or total bilirubin ? 3.0 x ULN with direct bilirubin within normal
range in patients with well documented Gilbert's Syndrome, which is defined as
presence of several episodes of unconjugated hyperbilirubinemia with normal
results from CBC count (including normal reticulocyte count and blood smear),
normal liver function test results, and absence of other contributing disease
processes at the time of diagnosis

- 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)

- More than 2 lines of chemotherapy for locally advanced and/or metastatic breast

- Brain metastasis

- Other malignancy (with the exception of adequately treated, basal or squamous
cell carcinoma, non-melanomatous skin cancer or curatively resected cervical

- Clinically significant (i.e. active) cardiovascular disease: cerebro-vascular
accident/stroke or myocardial infarction within 6 months prior to first study
medication; unstable angina; CHF of New York Heart Association (NYHA) Grade II
or higher; or serious cardiac arrhythmia requiring medication.

- Have had a major bowel resection that would alter oral drug absorption.

- Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative

- Are receiving concurrent administration of immunosuppressive therapy

- Concurrent participation in any therapeutic clinical trial

- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol
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