Clinical Trials /

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

NCT01805076

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
  • Official Title: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: A011104
  • SECONDARY ID: ACRIN 6694
  • SECONDARY ID: U10CA037447
  • SECONDARY ID: NCI-2012-02045
  • NCT ID: NCT01805076

Conditions

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

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.

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).

      Secondary objectives are:

        -  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

        -  To compare local recurrence rates between women who undergo BCT on the control arm to
           women who undergo BCT on the MRI arm

        -  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

        -  To compare the contralateral breast cancer rates in women randomized to preoperative
           breast MRI to those not receiving pre-operative breast MRI

        -  To compare the disease-free survival rates between women assessed preoperatively with
           breast MRI to those assessed without the use of breast MRI

        -  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

        -  To estimate the rate of MRI-guided localization assisted surgery

        -  To estimate the rate of multi-centric disease in the index breast for women in the MRI
           arm

        -  To evaluate the accuracy of index lesion characteristics and other factors in predicting
           multi-centricity in the cohort randomized to breast MRI

        -  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

        -  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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1 (control)OtherPatients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
    Arm 2 (experimental)ExperimentalPatients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.

      Eligibility 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 (< 10% by
                        immunohistochemistry IHC staining) and HER-2 negative breast cancer OR
      
                     -  ER negative/PR negative (< 10% 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.
      
                -  No patients with multicentric or multifocal disease scheduled to undergo multiple
                   lumpectomies. Multifocal disease that can be encompassed in a single operative bed can
                   be enrolled.
      
                -  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 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 registration
      
                -  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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Local-regional recurrence (LRR)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Re-operation rate
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis
      Time Frame:Within the first 6 months
      Safety Issue:
      Description:
      Measure:Time to contralateral breast cancer
      Time Frame:Up to 5 years post-randomization
      Safety Issue:
      Description:
      Measure:Disease-free survival (DFS)
      Time Frame:Up to 5 years post-randomization
      Safety Issue:
      Description:
      Measure:Overall survival
      Time Frame:Up to 5 years post-randomization
      Safety Issue:
      Description:
      Measure:Breast cancer specific survival will be measured
      Time Frame:Up to 5 years post-randomization
      Safety Issue:
      Description:
      Measure:Rate of MRI-guided localization assisted surgery (Arm B)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:False positive rate for MRI detection of multiple disease foci
      Time Frame:Up to 5 years
      Safety Issue:
      Description:

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Alliance for Clinical Trials in Oncology

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