Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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 patients with hormone receptor-positive metastatic breast cancer. The safety of these drugs will be studied as well as markers in the tumors that may help researchers predict the tumors' reaction to the treatment.

Key facts

Study ID: NCT00903006
Run by: M.D. Anderson Cancer Center
People needed: 11
Starts: 2009-11-01
Expected to finish: 2013-05-01
Last updated by the study team: 2015-02-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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