Status:
COMPLETED
Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HER2/Neu Positive
Invasive Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of entinostat when given together with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has spread from the o...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) for entinostat in combination with lapatinib (lapatinib ditosylate) in patients whom trastuzumab has failed for human epiderma...
Eligibility Criteria
Inclusion
- Patients have histological confirmation of invasive breast carcinoma
- Patients have locally recurrent or distant relapsed metastatic disease
- Patients have positive HER2 expression by immunohistochemistry (IHC) (3+) or fluorescence in situ hybridization (FISH) testing (\> 2.0 ratio)
- Patients are able to swallow and retain oral medication (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)
- Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must have received prior trastuzumab for \> 2 month period before disease recurrence or recurrence or progression while on trastuzumab-based therapy
- Patients have ability and willingness to sign written informed consent
- Female patients of childbearing potential (a female not free from menses \> 2 years or not surgically sterilized) must be willing to use an adequate barrier method of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study; male patients who are able to father children must use an adequate barrier method of contraception
- Female patients of childbearing potential must have negative serum pregnancy test within 14 days of starting protocol therapy
- Patients with brain metastasis have no signs of progressive disease 4 months after the completion of brain metastasis treatment (radiation therapy, surgery, etc.) do not require anticonvulsants or corticosteroids, and have been off such drugs for at least 7 days
- Both men and women and members of all races and ethnic groups are eligible for this trial
Exclusion
- Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, biological therapy and hormonal therapy) while taking study medication
- Serum bilirubin \>= 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>= 3 x ULN (with or without liver metastasis \[mets\])
- Absolute neutrophil count (ANC) \< 1.5
- Hemoglobin =\< 9
- Platelet =\< 140,000
- Patients have an active infection and require intravenous (IV) or oral antibiotics
- Cardiac arrhythmia requiring maintenance medication
- History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
- Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients' safety
- Serum creatinine \> 2.0 mg/dL
Key Trial Info
Start Date :
January 10 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01434303
Start Date
January 10 2012
End Date
February 16 2016
Last Update
May 20 2019
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030