TORI 104 Pre-Surgical Dasatinib

Status:

WITHDRAWN

TORI 104 Pre-Surgical Dasatinib

Lead Sponsor:

AHS Cancer Control Alberta

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 sh...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01410708

Last Update

February 17 2016

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