MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer

Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy

RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy.

PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: neoadjuvant therapy; Drug: systemic chemotherapy; Procedure: magnetic resonance spectroscopic imaging

Detailed Description

OBJECTIVES:

• To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time).
• To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis).

OUTLINE: This is a multicenter study.

Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Hull, England, United Kingdom, HU3 2KZ
      • Cactus Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

DISEASE CHARACTERISTICS:

• Newly diagnosed, histologically proven breast cancer

  • Stage T2-4B, N0-3C, and M0 disease
  • Locally advanced primary disease
• Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
• Scheduled for neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Medically stable
• No renal failure
• No serious breast trauma within the past 3 months
• No known allergic reaction associated with previous administration of a paramagnetic contrast agent

• No known contraindication to magnetic resonance (MR) scanning

  • Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
  • No disability preventing MR scanning in the prone position
  • No body habitus incompatible with MR system entry

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy

• No prior surgery or radiotherapy for cancer in the ipsilateral breast

  • More than 4 months since prior surgery to the ipsilateral breast for benign breast disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol
Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)

Collaborators and Investigators

• Sponsor: Cancer Clinical Trials Unit, Scotland
• Investigators: Principal Investigator: Lindsay W. Turnbull, MD, Hull Royal Infirmary

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CCTU-Neo-COMICE; CDR0000649054 (Registry Identifier: PDQ (Physician Data Query)); ISRCTN42613663; EU-20968