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

Cancer Clinical Trials Unit, Scotland

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging; Procedure: neoadjuvant therapy; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Drug: systemic chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00978770

ISRCTN42613663

CDR0000649054 (Registry Identifier)

CCTU-Neo-COMICE

EU-20968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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