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

NCT01110174 | Completed Results FDA Device

• 2 other identifiers: 216529CCSO 010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assess the Ability of the HD PET/CT to Predict Final Histopathologic NAC Response.

  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.

  After the first cycle of Neoadjuvant chemotherapy (NAC)

Secondary Outcomes (1)

• Correlate Serum Circulating BCa-related Glycan Profiles With Radiographic and Histopathologic Assessments of NAC Response.

  Baseline, during and after chemotherapy

Study Arms (1)

HD PET/CT

EXPERIMENTAL

utilization of PET/CT for diagnostic of breast cancer progression.

Diagnostic Test: HD PET/CT

Interventions

HD PET/CT DIAGNOSTIC_TEST

imaging

HD PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Dr. Martinez, left UC Davis in 2013 and Dr. Bold was listed as PI. No new participants were enrolled under Dr. Bold, and he does not have access to the data. UC Davis does not have any means of contacting Dr. Martinez pursuant to results entry.

Results Point of Contact

• Title: PI has left the institution, all efforts to locate PI have been exhausted.
• Organization: PI has left the institution, all efforts to locate PI have been exhausted.

steve.martinez@ucdmc.ucdavis.edu

Study Officials

• Steve Martinez, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 26, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 21, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-11

Locations

US (1)