TORI 104 Pre-Surgical Dasatinib

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will examine the anti-tumor activity, safety and tolerability of dasatinib in adjuvant breast cancer patients in a pre-surgical setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Dasatinib

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.