TORI 104 Pre-Surgical Dasatinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410708
Recruitment Status : Withdrawn
First Posted : August 5, 2011
Last Update Posted : February 17, 2016
Information provided by:
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Dasatinib Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Dasatinib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410708

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta Identifier: NCT01410708     History of Changes
Other Study ID Numbers: BR-1-0103
TORI 104
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
Human Breast Cancer Tissue

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action