Phase 2
Completed N=12
Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery
Estrogen Receptor-negative Breast Cancer · male breast cancer · Progesterone Receptor-negative Breast Cancer · Recurrent Breast Cancer
Source: ClinicalTrials.gov NCT00559507 ↗
Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Jan 2014
Primary outcomePrimary: Disease Control Rate (DCR) — 0 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate (DCR) |
— | — |
| SECONDARY Overall Response Rate (CR and PR) |
3; 6 | — |
| SECONDARY Median Time to Treatment Failure |
82 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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 4% with exercise
- Patients with metastatic disease may have received no more than 1 prior chemotherapy regimen
- No unresolved toxicity ≥ grade 3 from agents received more than 3 weeks earlier
- No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study
- No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry
- More than 7 days since prior and no concurrent use of specifically prohibited cytochrome P 450 3A4 (CYP3A4) agents
- No concurrent megestrol acetate, even when prescribed for appetite stimulation
- No other concurrent investigational or commercial agents for the treatment of breast cancer
- No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
- No concurrent megestrol acetate
Data sourced from ClinicalTrials.gov (NCT00559507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.