HER2 Positive Breast CarcinomaPhase 2NCT02827877
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
A Phase 2 study testing Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis and Pertuzumab in people with HER2 Positive Breast Carcinoma and Stage IIIA Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- What is being tested?
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis and Pertuzumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 26 Aug 2027
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be women who have histological confirmation of HER2 positive breast cancer
- The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI)
- The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
- Patients may not have received prior HER2 directed therapies
- Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)
- Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
- Ability to provide informed consent
- Negative Serum Pregnancy test
Who cannot join
- Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
- Concurrent malignancy other than non-melanoma skin cancer
- Patients must not have known metastatic disease
- Patients must not have received prior treatment for the current breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzum-Based Neoadjuvant Therapy
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a patient's response to trastuzumab and pertuzumab before surgery in patients with locally advanced HER2 positive breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.
SECONDARY OBJECTIVES:
- To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1 antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the HER2+/ER+ patients and in all patients.
II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete pathologic response (pCR) versus (vs) non-pCR patients.
OUTLINE:
Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and 2. Within 4 days after completion of PET scans, patients then receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.
After completion of study treatment, patients are followed up for 1 year.
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab, Positron Emission Tomography, Therapeutic Conventional Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Cu 64-DOTA-TrastuzumabRadiation
Also called 64Cu-DOTA-Trastuzumab
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PertuzumabBiological
Also called 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4
Given IV
Positron Emission TomographyProcedure or surgery
Also called PET Scan
Undergo PET
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
TrastuzumabBiological
Also called ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) | Experimental | Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Receives: Radiation: Copper Cu 64-DOTA-Trastuzumab; Other: Laboratory Biomarker Analysis; Biological: Pertuzumab; Procedure: Positron Emission Tomography; Procedure: Therapeutic Conventional Surgery; Biological: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).
The response assessment is performed at the time of definitive surgery. Patients' disease will be staged in the conventional manner according to the AJCC. The primary endpoint is complete pathologic response defined as no evidence of residual invasive cancer in either the breast or regional lymph nodes.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start14 Feb 2018
- Primary completion2 Jul 2020
- Study completion26 Aug 2027 (estimated)
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 HER2 Positive Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joanne Mortimer, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827877
- Sponsor's protocol ID
- 16079
- Other IDs
- FWA 00000692
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2016
- Last updated
- 2 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzum-Based Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT02827877
- Acronym / sponsor ID
- 16079
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a patient's response to trastuzumab and pertuzumab before surgery in patients with locally advanced HER2 positive breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.
SECONDARY OBJECTIVES:
- To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1 antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the HER2+/ER+ patients and in all patients.
II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete pathologic response (pCR) versus (vs) non-pCR patients.
OUTLINE:
Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and 2. Within 4 days after completion of PET scans, patients then receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.
After completion of study treatment, patients are followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) | Experimental | Radiation: Copper Cu 64-DOTA-Trastuzumab, Other: Laboratory Biomarker Analysis, Biological: Pertuzumab, Procedure: Positron Emission Tomography, Procedure: Therapeutic Conventional Surgery, Biological: TrastuzumabPatients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be women who have histological confirmation of HER2 positive breast cancer
- The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI)
- The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
- Patients may not have received prior HER2 directed therapies
- Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)
Key exclusion criteria (4 listed)
- Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
- Concurrent malignancy other than non-melanoma skin cancer
- Patients must not have known metastatic disease
- Patients must not have received prior treatment for the current breast cancer
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 |
|---|---|---|
| Copper Cu 64-DOTA-TrastuzumabAlso: 64Cu-DOTA-TrastuzumabGiven IV | Radiation | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
| PertuzumabAlso: 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4Given IV | Biological | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
| Positron Emission TomographyAlso: PET ScanUndergo PET | Procedure or surgery | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
| TrastuzumabAlso: ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2Given IV | Biological | Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) |
Primary outcome
Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).
Time frame: Up to 1 year
The response assessment is performed at the time of definitive surgery. Patients' disease will be staged in the conventional manner according to the AJCC. The primary endpoint is complete pathologic response defined as no evidence of residual invasive cancer in either the breast or regional lymph nodes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
Joanne Mortimer principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis and Pertuzumab in people with HER2 Positive Breast Carcinoma and Stage IIIA Breast Cancer, run by City of Hope Medical Center 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2023). 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?
Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy). (time frame: Up to 1 year). 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 2 Nov 2026.