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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Steve R. Martinez, MD, MAS, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01110174
First received: April 22, 2010
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Breast Cancer
Other: PET CT imaging
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Assess the ability of the HD PET/CT to predict final histopathologic NAC response. [ Time Frame: After the first cycle of Neoadjuvant chemotherapy (NAC) ] [ Designated as safety issue: No ]
    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:
  • Correlate serum circulating BCa-related glycan profiles with radiographic and histopathologic assessments of NAC response. [ Time Frame: Baseline, during and after chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: HD PET CT Other: PET CT imaging
imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110174

Contacts
Contact: Steve Martinez, MD 916 734 7265 steve.martinez@ucdmc.ucdavis.edu
Contact: Abby Olusanya, FNP 916 734 7502 abimbola.olusanya@ucdmc.ucdavis.edu

Locations
United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Steve MArtinez, MD    916-734-7265    steve.martinez@ucdmc.ucdavis.edu   
Contact: Abby Olusanya, FNP    9167347502    abimbola.olusanya@ucdmc.ucdavis.edu   
Principal Investigator: Steve Martinez, MD         
Sub-Investigator: Ramsey Badawi, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Steve Martinez, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Steve R. Martinez, MD, MAS, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01110174     History of Changes
Other Study ID Numbers: 200917637, CCSO 010
Study First Received: April 22, 2010
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014