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

NCT00978770 | Completed Phase 2

• 4 other identifiers: CCTU-Neo-COMICECDR0000649054ISRCTN42613663EU-20968
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

systemic chemotherapy DRUG

diffusion-weighted magnetic resonance imaging PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

magnetic resonance spectroscopic imaging PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Clinical Trials Unit, Scotland: lead

Study Sites (1)

Cactus Clinical Trials Unit

Hull, England, HU3 2KZ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lindsay W. Turnbull, MD

  Hull Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2009-09

Locations

GB (1)