Status:
COMPLETED
A Prospective Study to Evaluate FDG-PET, Breast MRI, and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer (LABC) Undergoing Neoadjuvant Chemotherapy
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Juravinski Cancer Centre Foundation
Conditions:
Locally Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound can be incorporated into the assessment of treatment responses in women with LABC undergoing neoadjuvant ch...
Detailed Description
Locally advanced breast cancer (LABC) is usually treated with neoadjuvant chemotherapy followed by surgery and radiation. At present, monitoring of tumour responses to chemotherapy is primarily carrie...
Eligibility Criteria
Inclusion
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma - not breast sarcoma or lymphoma)
- Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer.
- Patients must be able to undergo neoadjuvant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy
Exclusion
- Previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
- Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan).
- Previous chemotherapy or hormonal therapy for breast cancer.
- Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
- Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
- Pregnant or lactating females (e.g. positive serum B-hCG pregnancy test).
- Unable to lie supine for imaging with PET.
- Inadequate hematologic, renal and liver function as measured by CBC (WBC \< 4.0 x 109, Hb \< 100 g/L, plt count \< 100 x 109), and abnormal hepatic transaminases (AST, ALT, GGT, alkaline phosphatase \> 2x normal), elevated total bilirubin, and elevated serum creatinine (Cr \> 110 micromol/L).
- Any contraindication to undergoing MRI or PET.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00788489
Start Date
January 1 2006
End Date
April 1 2010
Last Update
October 4 2011
Active Locations (1)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2