Clinical Trials Logo
NCT number NCT03190083
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Nidhi Sharma, MD
Phone 216-444-9014
Email sharman2@ccf.org
Status Not yet recruiting
Phase N/A
Start date August 2017
Completion date April 2018

Clinical Trial Summary

The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.


Clinical Trial Description

Primary Objective:

The primary objective of the study is to measure the frequency with which DBT alters the surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional site of cancer or DCIS, will be taken into account when estimating the frequency of changes to surgical management.

Secondary objectives:

1. To measure the frequency and nature of additional findings like atypical pathology (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) , requiring surgical intervention).

2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from DBT.

3. To measure the proportion of patients undergoing additional work-up following the DBT, and the subset of these patients with benign findings (i.e. False Positives).


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults N/A
Recruiting NCT03284957 - Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Phase 1/Phase 2
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
Not yet recruiting NCT03252431 - Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy Phase 3
Not yet recruiting NCT03289039 - Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer Phase 2
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
Not yet recruiting NCT03273348 - Role of Oncoplastic Breast Surgery In Breast Cancer Treatement N/A
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Recruiting NCT03237572 - Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer Phase 1
Recruiting NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
Recruiting NCT02125019 - Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer N/A
Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
Recruiting NCT02955394 - Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Phase 2
Not yet recruiting NCT03200704 - A Study Assessing the Safety and Utility of IC2000 and SPY Fluorescence Imaging Systems in the Identification of Lymph Nodes During Lymphatic Mapping in Subjects With Breast Cancer Phase 3