Breast CancerENIGMANCT01110174
Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
A study testing HD PET/CT in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HD PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Assessing Response to Neoadjuvant Chemotherapy With Dedicated Breast High Definition PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- HD PET/CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD PET/CTDiagnostic test
imaging
| Study group | Role | What they receive |
|---|---|---|
| HD PET/CT | Experimental | utilization of PET/CT for diagnostic of breast cancer progression. Receives: Diagnostic Test: HD PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, during and after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Martinez, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110174
- Sponsor's protocol ID
- 216529
- Other IDs
- CCSO 010
- Acronym
- ENIGMA
- Status last verified
- Nov 2019
- First submitted
- 22 Apr 2010
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Response to Neoadjuvant Chemotherapy With Dedicated Breast High Definition PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
- ClinicalTrials.gov ID
- NCT01110174
- Acronym / sponsor ID
- ENIGMA / 216529
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD PET/CT | Experimental | Diagnostic Test: HD PET/CTutilization of PET/CT for diagnostic of breast cancer progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD PET/CTimaging | Diagnostic test | HD PET/CT |
Primary outcome
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.
1 secondary outcome
Correlate Serum Circulating BCa-related Glycan Profiles With Radiographic and Histopathologic Assessments of NAC Response.
Time frame: Baseline, during and after chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Martinez, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD PET/CT in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Ability of the HD PET/CT to Predict Final Histopathologic NAC Response. (time frame: After the first cycle of Neoadjuvant chemotherapy (NAC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.