TBCRC 017: Retrospective Project for the Predictive Accuracy of MRI to Determine Pathological Status in Patients Treated with Neoadjuvant Chemotherapy (NCT).

Back to Summary of Results

 

Purpose of the Study: 

The initial study was performed to estimate the accuracy of magnetic resonance imaging (MRI) prior to surgery, in predicting which patients had no tumor left in the breast, after being treated with Neoadjuvant Chemotherapy (pre-surgery chemotherapy).

The secondary analysis was performed to determine whether patients treated with pre-surgery chemotherapy, and imaged with MRI had differences in outcome based on the whether surgery removed the breast (mastectomy) or saved it (breast conserving surgery)

Sponsor: 

Translational Breast Cancer Research Consortium (TBCRC)

Participating Sites: 
  • Dana-Farber/ Harvard Cancer Center
  • Duke University Medical Cancer Center
  • Mayo Clinic Cancer Center
  • MD Anderson Cancer Center
  • University of Alabama, Birmingham
  • University of California, San Francisco
  • University of Chicago Medical Center
  • University of North Carolina, Chapel Hill
  • University of Pittsburgh Cancer Institute
Start Date & Stop Date: 

Date First Site Activated: February, 2010

Date Trial Closed to Accrual: January, 2015

Key Eligibility Requirements: 
  • Patients with early stage breast cancer treated between January 2002 and December 2013.
  • Received neoadjuvant chemotherapy (pre-surgery chemotherapy).
  • Received a breast MRI before and after drug treatment.
  • Records from surgery available for review.
Study Design: 
  • The initial study was a retrospective review of patient records among eight NCI (National Cancer Institute) Comprehensive Cancer Centers that are members of the Translational Breast Cancer Research Consortium (TBCRC).
    • Patients with MRIs performed before and after neoadjuvant chemotherapy between January 2002 and February 2011 fulfilled study criteria.
    • In addition to pre- and post- neoadjuvant chemotherapy MRI, eligible patients were required to have undergone definitive surgery, or surgery performed with curative intent including lumpectomies and mastectomies with or without reconstruction, with pathology available for review
  • The secondary analysis allowed institutions to continue to add more patients to the initial database and included patients from a ninth center.
Results: 
  • Data from 770 women treated at 8 NCI Comprehensive Cancer Centers was collected.
  • The initial study showed that in patients with aggressive breast cancer subtypes, the tumor initially seen on the MRI disappeared after neoadjuvant chemotherapy. These subtypes are HER2+, which tests positive for a protein called human epidermal growth factor receptor 2, that promotes the growth of cancer cells, and Triple Negative Breast Cancer which lacks three common characteristics: the estrogen receptor (ER) protein, the progesterone receptor (PR) protein, and the human epidermal growth factor receptor 2 (HER2).
  • There was no evidence of tumor cells seen after removal of the tumor site in the breast approximately 60% of the time.
  • The accuracy of breast MRI was 74% in predicting that patients undergoing preoperative chemotherapy had no tumor left.
  • The second study showed that in patients with early stage breast cancer, who received chemotherapy prior to surgery and pre-surgical imaging with MRI, breast-conserving surgery (removal of tumor and some of the surrounding tissue) produced cancer outcomes equal to mastectomy.
Next Steps: 

We are presently working on the oral presentation and manuscript for the second study. Other analyses on the dataset are planned.

Scientific Publications Available for this Clinical Trial: 

DeLosSantos, J., Cantor, A., Mcguire, K., Golshan, M., Meric-Bernstam, F., Horton, J., Nanda, R., Amos, K., Forero, A., Hudis, C., Meszoely, I., Hwang, E.S. Magnetic Resonance Imaging as a Predictor of Pathologic Response in Patients Treated with Neoadjuvant Systemic Treatment for Operable Breast Cancer:  Translational Breast Cancer Research Consortium Trial 017. 2011 SABCS, Poster P2-08-02.

DeLosSantos, J., Cantor, A., Mcguire, K., Golshan, M., Meric-Bernstam, F., Horton, J., Nanda, R., Amos, K., Forero, A., Hudis, C., Meszoely, I., Hwang, S. Surgical Patterns of Care after Magnetic Resonance Imaging in the Academic Setting in Patients with Operable Breast Cancer Treated with Neoadjuvant Systemic Therapy:  A Secondary Analysis of TBCRC 017. 2011 SABCS, Poster P2-15-01.

DeLosSantos, J., Cantor, A., Amos, K.,  Forero, A., Golshan, M., Horton, J.,  Hudis, C.,  Hylton, N.,  McGuire, K.,  Meric-Bernstam, F.,  Meszoely, I., Nanda, R., Hwang, S. Magnetic Resonance Imaging as a Predictor of Pathologic Response in Patients Treated with Neoadjuvant Systemic Treatment for Operable Breast Cancer (TBCRC 017). Cancer 119(10); 2013.

McGuire, K.P., DeLosSantos, J., Cantor, A., Forero, A., Golshan, M,, Meric-Bernstam, F., Horton, J.K., Amos, K.D., Hudis, C.A., Hylton, N.M., Meszoely, I.M., Nanda, R., Hwang, E.S. Nodal Patterns of Care in Patients with Invasive Breast Cancer Treated with Neoadjuvant Systemic Therapy: Results of a Secondary Analysis of TBCRC 017. 2013 SABCS, Poster P1-01-04.

McGuire, K.P.,  Hwang, E.S.,  Cantor, A.,  Golshan, M.,  Meric-Bernstam, F.,  Horton, J.K.,  Nanda, R.,  Amos, K.D.,  Forero, A.,  Hudis, C.A.,  Meszoely, I.,  DeLosSantos, J.F. Surgical Patterns of Care in Patients with Invasive Breast Cancer Treated with Neoadjuvant Systemic Therapy and Breast MR Imaging:  Results of a secondary analysis of TBCRC 017. Ann Surg Oncol 22(1): 2015.

De Los Santos J, Hyslop T, Alvarado M, Forero A, Golshan M, Hieken T, Horton J, Hudis C, McGuire K, Meric-Bernstam F, Nanda R, Zagar T, Hwang S. Treatment outcomes in patients with invasive breast cancer treated with neoadjuvant systemic therapy and breast MR imaging: Results of a secondary analysis of TBCRC 01. 2015 SABCS, Oral Presentation, S3-06.

 *This summary was reviewed by: Jennifer DeLosSantos, M.D.  This summary was also reviewed and approved by the members of the TBCRC Patient Advocate Working Group.