TORI 104 Pre-Surgical Dasatinib

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01410708
First received: August 4, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 NLM:


Further study details as provided by AHS Cancer Control Alberta:

Estimated Enrollment: 60
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410708

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01410708     History of Changes
Other Study ID Numbers: BR-1-0103, TORI 104
Study First Received: August 4, 2011
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 22, 2014