Breast Cancer Clinical Trial
Official title:
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
NCT number | NCT01410708 |
Other study ID # | BR-1-0103 |
Secondary ID | TORI 104 |
Status | Withdrawn |
Phase | Phase 2 |
First received | August 4, 2011 |
Last updated | February 12, 2016 |
Verified date | August 2011 |
Source | AHS Cancer Control Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
This study will examine the anti-tumor activity, safety and tolerability of dasatinib in adjuvant breast cancer patients in a pre-surgical setting.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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-T3. 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
AHS Cancer Control Alberta |
Canada,
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