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

NCT00788489 | Completed

• 1 other identifier: PETLAB-06Jan2006
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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 chemotherapy. A prospective cohort study will be conducted evaluating the ability of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to mastectomy.

Conditions

Locally Advanced Breast Cancer

Keywords

breast cancer; FDG-PET; MRI; chemotherapy; ultrasonography

Outcome Measures

Primary Outcomes (1)

• The primary outcomes are the sensitivity and specificity of physical examination, ultrasound, breast MRI and PET in predicting which patients have achieved a complete pathologic response (pCR) prior to undergoing surgery.

  5 years

Secondary Outcomes (3)

• Comparison of mean SUV uptake on FDG-PET for patients with pCR versus patients without pCR following neoadjuvant chemotherapy

  5 years

• The size of the tumour measured by physical examination, breast ultrasound and MRI just prior to surgery will be compared to pathology tumour measurements found following mastectomy.

  5 years

• Retrospective modelling to assess whether imaging test midway through chemotherapy affect management decisions

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 100 patients will be accrued over a 5-year period.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Som Mukherjee, MD MSc FRCP(C)

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: January 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

CA (1)