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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- 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

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No pacemaker


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Disease-free three-year survival

Safety Issue:


Principal Investigator

Nola M. Hylton, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco



Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Chicago Cancer Research Center Chicago, Illinois  60637
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Mayo Clinic Cancer Research Consortium Rochester, Minnesota  55905