Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:May 2002

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Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer


RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine
the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more
effective treatment.

PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in
women who are receiving chemotherapy for stage III breast cancer.


OBJECTIVES:

- Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced
magnetic resonance imaging (MRI) that are predictive of pathologic remissions and
survival in women with stage III breast cancer.

- Identify two groups of patients who have statistically different 3-year disease-free
survival using MRI measurements of tumor response to neoadjuvant chemotherapy.

- Determine whether MRI measurements of tumor response after the first course of
neoadjuvant chemotherapy can predict which of these patients will ultimately have poor
clinical response to chemotherapy.

- Compare the accuracy of MRI vs mammography in predicting the extent of residual disease
as determined by histopathology in these patients.

- Determine whether initial MRI tumor characteristics (morphologic and vascular patterns)
predict pathological response and/or survival in these patients.

- Estimate the conditional probability of response to paclitaxel based on MRI
measurements of response to doxorubicin and cyclophosphamide in these patients.

OUTLINE: This is a multicenter study.

Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance
imaging (MRI) and magnetic resonance spectroscopy of the breast within 4 weeks before
beginning neoadjuvant chemotherapy, 20-28 hours or 48-96 hours after the first course of
doxorubicin and cyclophosphamide (Type 1 chemotherapy), between Type 1 chemotherapy and
paclitaxel chemotherapy regimens (Type 2 chemotherapy) (MRI only) if the patient continues
to Type 2 chemotherapy, and 3-4 weeks after final neoadjuvant chemotherapy treatment (1-2
weeks before surgery).

Patients also undergo mammograms and possibly ultrasounds that coincide with the first and
last MRI. Core or needle biopsy is performed after the first MRI but before the first course
of Type 1 chemotherapy and between Type 1 chemotherapy and Type 2 chemotherapy (if the
patient continues to Type 2 chemotherapy).

Patients are followed every 6 months for 7-10 years.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed stage III breast cancer per CALGB criteria

- Tumor that is ≥ 3 cm

- Concurrent enrollment in the CALGB-49808 trial OR

- Receiving neoadjuvant chemotherapy consisting of a taxane-based regimen alone
(chemotherapy Type 1) or followed by an anthracycline-based regimen (chemotherapy
Type 2) and enrolled in CALGB Correlative Science trial 150007

- Patients who decline participation in CALGB-49808 or those with HER-2/neu-negative
tumors are eligible if tumor is at least 3 cm and they choose to undergo neoadjuvant
chemotherapy

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No pacemaker

Other

- Not pregnant

- Fertile patients must use effective contraception

- No contraindications to MRI (e.g., ferromagnetic prosthesis, cranial vascular clips,
or claustrophobia)

- Creatinine clearance > 30 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified
We found this trial at
11
sites
3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
(202) 687-2110
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
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Washington,
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1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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Birmingham, AL
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5841 S Maryland Ave # Mc1140
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Cancer Research Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
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Dallas, TX
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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Lebanon, NH
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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Minneapolis, MN
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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New York, NY
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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Chapel Hill, NC
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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Rochester, Minnesota 55905
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Rochester, MN
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