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

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ClinicalTrials.gov Identifier: NCT01805076
Recruitment Status : Active, not recruiting
First Posted : March 6, 2013
Last Update Posted : July 20, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE February 24, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE February 2014
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Local-regional recurrence (LRR) [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • Local-regional recurrence (LRR) [ Time Frame: 5 years ]
  • Proportion of women with MRI detected multiple foci disease (Arm B) [ Time Frame: Up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
  • Re-operation rate [ Time Frame: Up to 5 years ]
  • Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis [ Time Frame: Within the first 6 months ]
  • Time to contralateral breast cancer [ Time Frame: Up to 5 years post-randomization ]
  • Disease-free survival (DFS) [ Time Frame: Up to 5 years post-randomization ]
  • Overall survival [ Time Frame: Up to 5 years post-randomization ]
  • Breast cancer specific survival will be measured [ Time Frame: Up to 5 years post-randomization ]
  • Rate of MRI-guided localization assisted surgery (Arm B) [ Time Frame: Up to 5 years ]
  • False positive rate for MRI detection of multiple disease foci [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • Re-operation rate [ Time Frame: Up to 5 years ]
  • Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis [ Time Frame: Within the first 6 months ]
  • Time to contralateral breast cancer [ Time Frame: Up to 5 years ]
  • Disease-free survival (DFS) [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Breast cancer specific survival will be measured [ Time Frame: Up to 5 years ]
  • Rate of MRI-guided localization assisted surgery (Arm B) [ Time Frame: Up to 5 years ]
  • Proportion of women with MRI detected multiple foci disease (Arm B) [ Time Frame: Up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
Official Title  ICMJE Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: Breast surgery
  • Procedure: Magnetic resonance imaging
  • Procedure: Mammography
Study Arms  ICMJE
  • Arm 1 (control)
    Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
    Interventions:
    • 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.
    Interventions:
    • Procedure: Breast surgery
    • Procedure: Magnetic resonance imaging
    • Procedure: Mammography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 7, 2020)
317
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
536
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805076
Other Study ID Numbers  ICMJE A011104
ACRIN 6694
U10CA037447 ( U.S. NIH Grant/Contract )
NCI-2012-02045 ( Registry Identifier: Clinical Trial Reporting Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • American College of Radiology Imaging Network
Investigators  ICMJE
Study Chair: Isabelle Bedrosian, MD M.D. Anderson Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP