Accuracy of Contrast-Enhanced Digital Mammography for the Assessment of Chemotherapy Response in Patients with Primary or Recurrent Invasive Breast Cancer

Status: administratively complete

This phase III trial investigates the diagnostic accuracy of contrast-enhanced digital mammography (CEDM) in predicting early response to pre-surgical chemotherapy or endocrine therapy compared to mammography, ultrasound, and/or breast magnetic resonance imaging in patients with invasive breast cancer that is the original or first tumor (primary) or has come back (recurrent). CEDM is an imaging technique that allows digital mammography to be used with contrast enhancement to help visualize cancers that would otherwise not be seen on standard mammography. A contrast agent is a substance that is used to increase the contrast of structures or fluids in medical imaging. Learning about the diagnostic accuracy of CEDM in predicting chemotherapy response and testing how much cancer is left in breast may help researchers with accurate surgical removal of the cancer.

Inclusion Criteria

Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by imaging)
Available mammography and ultrasound imaging of the existing index cancer, with orthogonal measurements
Prior history of ipsilateral or contralateral breast cancer, presenting with a new primary or recurrent disease
Patients who were determined to be candidates for either neoadjuvant chemotherapy or neoadjuvant endocrine therapy by the treating physician

Exclusion Criteria

History of ipsilateral mastectomy
Women who already started neoadjuvant chemotherapy or endocrine therapy
Woman who may be pregnant
Prior history of anaphylactic or anaphylactoid reaction to any contrast
Prior allergy to iodine or iodinated contrast

PRIMARY OBJECTIVE:

I. To investigate the diagnostic accuracy of contrast-enhanced spectral mammography (CEDM) in predicting early neoadjuvant therapy response and pathologic complete response (pCR).

SECONDARY OBJECTIVES:

I. To investigate the correlation of CEDM pre-operative lesion size and final pathological size.

II. To determine additional sites of disease in the ipsilateral or contralateral breast identified by CEDM.

EXPLORATORY OBJECTIVES:

I. To determine the optimal post neoadjuvant therapy CEDM timing which helps demonstrate the residual disease extent.

II. To identify any patient preference differences between CEDM and breast magnetic resonance imaging (MRI).

OUTLINE:

Patients receive iopamidol intravenously (IV) and then undergo CEDM over 30 minutes at baseline (prior to the start of chemotherapy), mid-chemotherapy, and post-chemotherapy/pre-surgery.

After completion of study, patients are followed up at 30 days after completion of definitive surgery.

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Accuracy of Contrast-Enhanced Digital Mammography for the Assessment of Chemotherapy Response in Patients with Primary or Recurrent Invasive Breast Cancer

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