NCT01410708WithdrawnPhase 2
A Pre-Surgical Study to Evaluate Molecular Changes That Occur in Human Breast Cancer Tissue After Short Term Exposure to Dasatinib and To Correlate These Alterations With Pharmacokinetics Parameters
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- AHS Cancer Control Alberta
- Locations
- 1
Study Overview
Brief Summary
This study will examine the anti-tumor activity, safety and tolerability of dasatinib in adjuvant breast cancer patients in a pre-surgical setting.
Detailed Description
Primary Objective: To evaluate the molecular changes which occur in human breast cancer tissue after short-term exposure to dasatinib.
Secondary Objectives:
" To evaluate the molecular effects of short term dasatinib exposure in peripheral blood and on SRC (an oncogene) and EPHA2 signaling pathways in non-tumor cells (peripheral blood).
" To correlate the pharmacokinetic parameters with molecular changes detected in breast cancer tissues and peripheral blood " To evaluate the tolerability and safety of short-term exposure to daily dose of 100 mg twice daily of dasatinib administration
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed signed consent, female, over 18 years of age nad Karnofsky performance status index greater than 80%.
- •Histologically proven invasive breast cancer through either core needle biopsy or an incisional biopsy. Excisional biopsy not allowed.
- •Tumor must be confined to either the breast or to the breast and ipsilateral axilla. Tumor size of greater than 2cm (T1 with T=2m, T2-T
- •Patient can have clinically positive (N1) or clinically negative)
- •Neutrophils greater than 1.5 x 109/L, Platelets greater tahn 100 x 109/L, Hemoglobin greater than 10g/dL.
- •Total bilirubin less than 1 UNL, AST and ALT less than 2.5 UNL, Alk phos less than 5 UNL, creatinine less than 175umol/L (2mg/dL)
- •not more than 28 days from the time of the initial diagnosis and 8 days from registration to the first dose of dasatinib shall elapse.
- •Patients must be accessible for treatment and the 30-day follow-up and compliant with study procedures.
- •Negative pregnancy test within 7 days prior to registration for women of childbearing potential.
Exclusion Criteria
- •Prior or concurrent systemic anticancer therapy
- •Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive breast cancer.
- •Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
- •Any T1 (with exception of T1 with T=2cm) or T4 or N2 or known N3 or M1 breast cancer.
- •Concurrent or congestive heart failure, unstable angina pectoris or MI in past 6 months; uncontrolled hypertension or high risk uncontrolled arrhythmias; any history of significant ventricular arrhythmia.
- •History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding of informed consent; active uncontrolled infection.
- •Past or prior history of neoplasm other than breast carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated.
- •Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 2 weeks prior to registration.
- •Concurrent treatment with other experimental drugs or treatment wih investigational drugs with 30 days of registration.
- •Prior hormonal therapy with any hormonal agents such as ralozifene, Tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention.
Investigators
Study Sites (1)
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