Skip Navigation Links
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
Overall Recruitment Status: Enrollment complete
 
Official Title
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
 
Region Sponsors
California - Northern
Alliance for Clinical Trials in Oncology
 
Acronym NCT No.
NCT01805076
 
Study Type Phase
INTERVENTIONAL
Phase III
 
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
Additional Principal Investigator for this trial: Jacob Mishell, San Francisco, CA 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).
 
 
 
Inclusion 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,
 
Exclusion Criteria
  • 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, 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.
 
Keywords and/or Specific Medical Conditions
  • A011104
  • Neoplasms by Site
  • A011104/6694 Breast Neoplasms
  • Skin Diseases
  • Breast Diseases
  • Triple Negative Breast Neoplasms
  • Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- CTP Team, RN
-ctpcollaborate@kp.org
-Vallejo Medical Center


smilelady1
Do you want to receive
Email Alerts?
Sign Up Here!