TORI 104 Pre-Surgical Dasatinib

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01410708
• Date of registration: 04/08/2011
• Primary sponsor: Alberta Health Services
• Public title: TORI 104 Pre-Surgical Dasatinib
• Scientific 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
• Date of first enrolment: July 2011
• Target sample size: 60
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01410708
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Dasatinib

Secondary ID(s)

BR-1-0103

TORI 104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors