Working… Menu

Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms (ENIGMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110174
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : November 13, 2019
Last Update Posted : November 21, 2019
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
A pilot study of adult (≥ 18 years) women with stage II-III breast cancer who will receive preoperative chemotherapy prior to mastectomy. Patients will have real-time serum glycan profiling, expression of tissue MUC 1 oncoprotein isoforms to predict neoadjuvant chemotherapy response and additional mammography and HD PET/CT examinations to assess response. The investigators hypothesize that a functional tumor assessment utilizing high-definition positron emission tomography/computed tomography (HD PET/CT), real-time serum glycan profiling, and expression of tissue MUC 1 oncoprotein isoforms will predict neoadjuvant chemotherapy response in breast cancer patients.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: HD PET/CT Not Applicable

Detailed Description:
This is a non-randomized clinical trial pilot study. Consenting adult (≥ 18 years) women with stage II-III breast cancer undergoing will receive neoadjuvant chemotherapy with a standard ACT regimen prior to mastectomy. Prior to beginning chemotherapy, patients will receive a baseline mammogram, breast HD PET/CT, and blood draw. Not more than 7 days prior to the second cycle of chemotherapy, patients will have both HD PET/CT and diagnostic mammography images taken to assess early response to treatment. Patients will have two additional mammography and HD PET/CT examinations: one after the first cycle of chemotherapy, and another upon completion of the last cycle of chemotherapy but before mastectomy. The investigators will collect data on the size (maximum diameter, estimated volume) and 18FDG uptake (SUV) of the known primary breast cancer on HD PET/CT. Blood will be sampled from patients at 12 separate time points during the study for glycan analysis. At least 3 ml will be taken with each blood draw. The first blood draw will be taken when the patient agrees to enroll in the study. The second blood draw will be taken prior to the first cycle of chemotherapy. Thereafter, blood will be drawn for serum glycan analysis after each cycle of chemotherapy is completed. After the patient undergoes mastectomy, tissue will be collected for MUC-1 assay and two additional blood draws will be taken.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessing Response to Neoadjuvant Chemotherapy With Dedicated Breast High Definition PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
Study Start Date : March 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HD PET/CT
utilization of PET/CT for diagnostic of breast cancer progression.
Diagnostic Test: HD PET/CT

Primary Outcome Measures :
  1. Assess the Ability of the HD PET/CT to Predict Final Histopathologic NAC Response. [ Time Frame: After the first cycle of Neoadjuvant chemotherapy (NAC) ]
    Patients will have a HD PET/CT at baseline and another after the first cycle of NAC and upon completion.The goal is to distinguish NAC responders from non-responders and to accurately identify the size and extent of residual disease.

Secondary Outcome Measures :
  1. Correlate Serum Circulating BCa-related Glycan Profiles With Radiographic and Histopathologic Assessments of NAC Response. [ Time Frame: Baseline, during and after chemotherapy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must sign informed consent to participate in the study.
  • Patient must be ≥ 18 years of age.
  • Histologic diagnosis of invasive breast cancer(ductal or lobular)
  • Stage II or III breast cancer and considered a candidate for curative mastectomy.
  • Selected mastectomy for surgical option of treatment.
  • Patient must agree to receive standard or dose-dense adriamycin, cyclophosphamide, and taxane-based chemotherapy given preoperatively.
  • Patient must have the following preoperative laboratory values confirmed within 28 days prior to registration: Creatinine ≤ 1.5 times ULN. Platelets ≥ 90,000/mm3. White blood count ≥ 1,500/mm3. PT/PTT ≤ the institution ULN. Patients of child-bearing potential must have a negative urine or serum pregnancy test.
  • If a patient is a cancer survivor, the patient must have undergone potentially curative therapy for all prior malignancies, with no evidence of prior malignancy for at least 5 years (except for effectively treated basal cell or squamous cell carcinoma of the skin, or carcinoma-in-situ of the cervix treated by surgery alone).
  • The primary breast tumor must be detectable by mammogram at the time of diagnosis
  • Estimated cardiac ejection fraction ≥ 50% by echocardiogram or MUGA
  • ECOG performance status 0-1.

Exclusion Criteria:

  • Non-invasive breast cancer, benign breast disease, or tumor histology other than stage II or stage III invasive ductal carcinoma, invasive lobular carcinoma, or mixed ductal and lobular carcinoma.
  • The patient has known distant metastatic disease.
  • The patient wishes to pursue breast conservation.
  • The patient is male.
  • The patient is receiving preoperative chemotherapy other than adriamycin, cyclophosphamide, and a taxane (ACT) in standard or dose-dense fashion.
  • The patient is pregnant or breast feeding.
  • The primary tumor is not visualized by mammogram at the time of diagnosis.
  • The patient's estimated cardiac ejection fraction is <50% by echocardiogram or MUGA.
  • The patient has a documented intravenous contrast allergy or iodine allergy.
  • Her-2/neu positive patients by IHC or FISH who receive trastuzumab neoadjuvantly; patients who are Her-2/neu positive but elect not to receive trastuzumab neoadjuvantly are still eligible for participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110174

Layout table for location information
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Layout table for investigator information
Principal Investigator: Steve Martinez, MD University of California, Davis

Layout table for additonal information
Responsible Party: University of California, Davis Identifier: NCT01110174     History of Changes
Other Study ID Numbers: 216529
CCSO 010
First Posted: April 26, 2010    Key Record Dates
Results First Posted: November 13, 2019
Last Update Posted: November 21, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes