MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
American College of Radiology Imaging Network
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01805076
First received: February 24, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.


Condition Intervention Phase
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
Procedure: Breast surgery
Procedure: Magnetic resonance imaging
Procedure: Mammography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Local-regional recurrence (LRR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-operation rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis [ Time Frame: Within the first 6 months ] [ Designated as safety issue: No ]
  • Time to contralateral breast cancer [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS) [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Breast cancer specific survival will be measured [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Rate of MRI-guided localization assisted surgery (Arm B) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of women with MRI detected multiple foci disease (Arm B) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 536
Study Start Date: February 2014
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 (control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
Procedure: Breast surgery Procedure: Mammography
Experimental: Arm 2 (experimental)
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.
Procedure: Breast surgery Procedure: Magnetic resonance imaging Procedure: Mammography

Detailed Description:

This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast conserving surgery by conventional clinical criteria will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Patients will be assigned to standard pre-operative breast cancer disease assessment without the addition of MRI prior to breast conserving surgery or standard pre-operative breast cancer disease assessment with the use of MRI prior to breast conserving surgery. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or HER-2 amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm). The secondary objectives for this study are:

  1. To compare the re-operation rates following attempted breast conserving therapy between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI
  2. To compare local recurrence rates between women who undergo BCT on the control arm to women who undergo BCT on the MRI arm
  3. To compare the conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis within the first 6 months of attempting BCT (prior to the administration of RT) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI
  4. To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI
  5. To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI
  6. To compare breast cancer specific and overall survival outcomes of women assessed preoperatively with breast MRI to those assessed without the use of breast MRI
  7. To estimate the rate of MRI-guided localization assisted surgery
  8. To estimate the rate of multi-centric disease in the index breast for women in the MRI arm
  9. To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI
  10. To assess the positive predictive values (PPV) of MRI in detecting ipsilateral multi-centric disease and contralateral disease in women with breast cancer undergoing preoperative breast MRI
  11. To estimate the false positive rate for detection of multiple foci of breast cancer by MRI

All registered patients will be monitored for relapse and survival for 5 years from the date of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for local, regional, distant relapse and vital status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.
  • Patients must have either:


    • Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 1% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR

    • ER negative/PR negative (< 1% by IHC staining) and HER-2 positive tumors
    • HER-2 status will be determined as per the 2013 ASCO CAP guidelines:

      • HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH
      • HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH
  • 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 history of chemotherapy for cancer within 6 months prior to registration
  • 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 and/or tomogram. 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 follow):


    • 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 7 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 registration
  • 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 within 7 days 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805076

Locations
United States, Texas
Doctors Hospital of Laredo Recruiting
Laredo, Texas, United States, 78045
Contact: Gary Unzeitig, M.D.    956-523-2000      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
American College of Radiology Imaging Network
Investigators
Study Chair: Isabelle Bedrosian, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01805076     History of Changes
Other Study ID Numbers: A011104, ACRIN 6694, U10CA037447, NCI-2012-02045
Study First Received: February 24, 2013
Last Updated: March 24, 2014
Health Authority: United States: NCI Central Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014