Status:
TERMINATED
Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goals of this clinical research study are to learn the tolerable and effective doses of the drug MK-0646 that can be given in combination with Sprycel (dasatinib) and Faslodex (fulvestrant) to pat...
Detailed Description
The Study Drugs: Fulvestrant is designed to block estrogen from helping breast cancer tumor cells grow. By blocking estrogen, it may stop tumor growth. Dasatinib is designed to change the function o...
Eligibility Criteria
Inclusion
- For the Phase I: Patients with histologically or cytologically confirmed diagnosis of metastatic hormone receptor-positive HER2-negative breast cancer who have received up to one line of endocrine therapy for metastatic disease.
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) or evaluable disease (e.g., bone metastasis, or lesions which do not fulfill RECIST criteria for metastatic disease)
- Age \>/= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
- Required laboratory values: Absolute neutrophil count (ANC)\>/= 1500 cells/mm\^3, platelet count \>/= 100,000 cells/mm\^3, hemoglobin \>/= 9 gm/L; bilirubin \</= 1.5 \* upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \</= 2.5 \* ULN; serum creatinine \</= 2.0 \* ULN
- Ability to understand the requirements of the study, provided written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
- Patients must be postmenopausal (\> 12 months of amenorrhea, bilateral oophorectomy).
- Patients must have received prior anti-estrogen therapy in the adjuvant setting.
- Patients may have easily accessible tumors for biopsy (confirmed by interventional radiology).
- Patients must consent to biopsies.
- For the Phase II: Patients with histologically or cytologically confirmed diagnosis of metastatic hormone receptor-positive, HER2-negative, breast cancer who have received up to one line of endocrine therapy for metastatic disease.
- Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, or lesions which do not fulfill RECIST criteria for metastatic disease)
- Age \>/= 18 years
- ECOG performance status of \</= 2
- Required Laboratory Values: ANC \>/= 1500 cells/mm\^3, platelet count \>/= 100,000 cells/mm\^3, hemoglobin \>/= 9 gm/L, Bilirubin \</= 1.5 \* ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \</= 2.5 \* ULN
- Serum creatinine \</= 2.0 \* ULN
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
- Patients must be postmenopausal (\> 12 months of amenorrhea, bilateral oophorectomy).
- Patients must have received prior anti-estrogen therapy in the adjuvant setting.
- Patients may have easily accessible tumors for biopsy (confirmed by interventional radiology).
- Patients must consent to biopsies.
Exclusion
- For the Phase I: History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix
- Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, ongoing or recent gastrointestinal bleed, hepatic or cardiac compromise, hypocalcemia, or known platelet function abnormality).
- Concomitant medication known to prolong QT interval, unless discontinued \>/= 7 days of starting dasatinib therapy.
- Newly diagnosed (within 3 months before enrollment) or poorly controlled (defined as a fasting serum glucose \> 160 mg/dl or hemoglobin A1c \> 8% at screening), type 1 or 2 diabetes mellitus.
- Active or untreated brain metastasis
- Pleural or pericardial effusion of any grade
- Bone only metastases
- Patients for whom endocrine therapy is not appropriate (i.e. life threatening metastatic disease).
- Patients requiring therapeutic anticoagulation (Warfarin 1 mg for port maintenance is allowed).
- For the Phase II: History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix
- Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, ongoing or recent gastrointestinal bleed, hepatic or cardiac compromise, hypocalcemia, or known platelet function abnormality).
- Concomitant medication known to prolong QT interval, unless discontinued \>/= 7 days of starting dasatinib therapy.
- Newly diagnosed (within 3 months before enrollment) or poorly controlled (defined as a fasting serum glucose \> 160 mg/dl or hemoglobin A1c \> 8% at screening), type 1 or 2 diabetes mellitus.
- Active or untreated brain metastasis
- Pleural or pericardial effusion of any grade
- Bone only metastases
- Patients for whom endocrine therapy is not appropriate (i.e. life threatening metastatic disease).
- Patients requiring therapeutic anticoagulation (Warfarin 1 mg for port maintenance is allowed).
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00903006
Start Date
November 1 2009
End Date
May 1 2013
Last Update
February 2 2015
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030