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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000649054 | Registry Identifier | PDQ (Physician Data Query) | |
| ISRCTN42613663 | |||
| EU-20968 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systemic chemotherapy | Drug | |||
| diffusion-weighted magnetic resonance imaging | Procedure | |||
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | |||
| magnetic resonance spectroscopic imaging | Procedure | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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DISEASE CHARACTERISTICS:
Newly diagnosed, histologically proven breast cancer
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
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy
No prior surgery or radiotherapy for cancer in the ipsilateral breast
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay W. Turnbull, MD | Hull Royal Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cactus Clinical Trials Unit | Hull | England | HU3 2KZ | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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