Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Estrogen Receptor-negative Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Key facts

Study ID

NCT00559507

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2007-10-01

Expected to finish

2011-02-01

Last updated by the study team

2014-04-30

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed carcinoma of the breast
• Unresectable disease
• Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage IV) disease
• Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as < 10% expression by immunohistochemistry (IHC)
• Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors [RECIST]) as ≥ 1 unidimensionally measurable lesion ≥ 20mm by conventional techniques or ≥ 10 mm by spiral computed tomography (CT) scan
• Measurable target lesions must not be in a previously irradiated field
• Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen
• Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease
• Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification > 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively
• No known brain metastases
• Male and female patients eligible
• Menopausal status not specified
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Karnofsky PS 60-100%)
• Life expectancy > 3 months
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin > 9 g/dL
• Total bilirubin normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Urine protein creatinine (UPC) ratio must be ≤ 1.0
• Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to be eligible for study
• Not pregnant or nursing
• Women of child-bearing potential and men must use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to, during, and for 8 weeks after completion of study therapy
• Able to understand and willing to sign a written informed consent document

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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