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Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

18 Years
Not Enrolling
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Triple-negative Breast Cancer

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Trial Information

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Inclusion Criteria

- Female. Men are excluded from this study because the number of men with breast cancer
is insufficient to provide a statistical basis for assessment of effects in this
subpopulation of people with breast cancer.

- Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0,
T0-2 N1 M0)

- Patients must have either:
* Estrogen receptor (ER) negative/progesterone receptor
(PR) negative (< 1% by immunohistochemistry IHC staining) and HER-2 negative (IHC 0,
1+ or fluorescence in situ hybridization [FISH] =< 2) breast cancer OR
* ER
negative/PR negative (< 1% by IHC staining) and HER-2 amplified tumors as determined
IHC 3+ or by FISH (amplification > 2.2)

- No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in
situ (DCIS)

- No patients with bilateral breast cancer

- No patients with known deleterious mutations in breast cancer (BRCA) genes

- No current history of receiving hormonal therapy, tamoxifen, and or aromatase
inhibitors for therapeutic measures

- No current or recent (6 months prior to the MRI) history of chemotherapy for cancer

- No patients scheduled to receive neoadjuvant chemotherapy or partial breast
irradiation following breast conserving surgery

- Eligible for BCT based on clinical examination, mammography and, if standard practice
at a given institution, ultrasound. Women who cannot be appropriately selected for
BCT based on these standard imaging studies, and for whom additional imaging is
recommended to clarify local disease extent, will not be eligible for this trial

- Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions
* No history of untreatable claustrophobia
* No presence of metallic objects
or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips,
surgical clips, prostheses, artificial hearts, valves with steel parts, metal
fragments, shrapnel, tattoos near the eye, or steel implants)
* No history of sickle
cell disease
* No contraindication to intravenous contrast administration
* No known
allergy-like reaction to gadolinium or moderate or severe allergic reactions to one
or more allergens as defined by the American College of Radiology (ACR); patient may
be eligible if willing to undergo pre-treatment as defined by the institution's
policy and/or ACR guidance
* No findings consistent with renal failure, as determined
by glomerular filtration rate (GFR) < 30
mL/min/1.73 m^2 based on a serum creatinine
level obtained within 28 days prior to registration
* Weight lower than that
allowable by the MRI table

- No prior MRI of study breast within the 12 months prior to the study MRI; no initial
biopsy-proven breast cancer diagnosis, including fine-needle aspiration (FNA) in
either breast, greater than 60 days prior to the MRI

- No history of breast biopsy (including FNA) of the study breast within 6 months prior
to the MRI

- Non-pregnant and non-lactating; patients of child-bearing potential must have a
negative pregnancy test prior to registration; perimenopausal patients must be
amenorrheic > 12 months to be considered not of child-bearing potential

- >= 18 years of age

- Signed study-specific informed consent prior to registration

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Local-regional recurrence (LRR)

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Isabelle Bedrosian, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Alliance For Clinical Oncology Trials/Cancer and Leukemia Group B


United States: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • HER2-positive Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms