Breast Cancer MetastaticPREDICT-HERNCT07586215
HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
An observational study of Breast Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 86 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- PET
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 11 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: advanced breast cancer patients
Who may be able to join
- Age ≥ 18 years.
- Histopathologically confirmed unresectable locally advanced or metastatic breast cancer, with documented prior immunohistochemistry (IHC) results indicating HER2-positive (IHC 3+, or IHC 2+ with positive FISH) or HER2-low (IHC 1+, or IHC 2+ with negative FISH) expression.
- For patients with hormone receptor-positive (HR+), HER2-negative breast cancer, patients must have received prior treatment with a CDK4/6 inhibitor in the locally advanced or metastatic setting, or experienced disease recurrence during adjuvant intensified CDK4/6 inhibitor therapy or within 12 months after completing adjuvant intensified CDK4/6 inhibitor therapy. (HR-positive is defined as ≥ 1% of tumor cells demonstrating positive ER staining by IHC; HER2-negative is defined as IHC score 0 or 1+, or IHC score 2+ with no evidence of in situ hybridization [ISH] gene amplification, or no evidence of ISH gene amplification in the absence of an IHC test.)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Documented radiological or objective evidence of disease progression on or after the most recent line of systemic therapy prior to initiating study treatment.
- Life expectancy ≥ 12 weeks at the time of screening.
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- Presence of at least one lesion (measurable and/or non-measurable) that can be accurately evaluated at baseline by CT (or MRI if CT is contraindicated) and is suitable for repeated assessment according to RECIST v1.1.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.
- Adequate organ and bone marrow function within 14 days prior to randomization. For all laboratory parameters listed below, the most recently obtained values must meet the eligibility criteria:
- Hemoglobin ≥ 9.0 g/dL;
- Absolute neutrophil count (ANC) ≥ 1,500/mm³;
- Platelet count ≥ 100,000/mm³;
- At baseline, total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) in the absence of liver metastases, or < 3.0 × ULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or documented liver metastases;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (< 5.0 × ULN for patients with liver metastases);
- Serum albumin ≥ 2.5 g/dL;
- Creatinine clearance (CrCl) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
- International Normalized Ratio (INR) or prothrombin time (PT), and partial thromboplastin time or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Female patients must refrain from donating eggs (oocytes) or retrieving/banking eggs for personal use from the screening period, throughout the entire study treatment period, and for at least 7 months after the final dose of study treatment. Breastfeeding must be discontinued during this period. Patients wishing to preserve eggs/fertility should consider undergoing these procedures prior to randomization in this study.
Who cannot join
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, uncontrolled or significant cardiovascular disease, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction or symptomatic congestive heart failure (CHF) (NYHA Class II to IV) within 6 months prior to randomization. Patients with troponin levels above the Upper Limit of Normal (ULN) (as defined by the manufacturer) at screening without any symptoms related to myocardial infarction should undergo cardiac consultation prior to randomization to rule out myocardial infarction;
- Uncontrolled hypertension;
- Uncontrolled and/or clinically significant arrhythmias.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroid treatment, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
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- Patients who have used immunosuppressive agents within 14 days prior to the first dose of study drug, with the exception of those using intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose less than 10 mg/day prednisone or an equivalent dose.
- Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, significant pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disease with associated pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), and/or prior lung resection.
- Uncontrolled infection requiring intravenous antibiotics, antiviral, or antifungal medications.
- Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring corticosteroid or anticonvulsant treatment to control associated symptoms. Subjects with clinically non-active brain metastases may be included in this study. If subjects have received treatment for brain metastases, are no longer symptomatic, do not require corticosteroids or anticonvulsants, and have recovered from acute toxicities of radiotherapy, they may be enrolled in this study.
- Active primary immunodeficiency, known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B or C infection. Among patients who are Hepatitis C antibody positive, only those with a negative polymerase chain reaction (PCR) for HCV RNA are eligible for study enrollment.
- Unresolved toxicities from prior anti-cancer therapy, defined as toxicities not resolved to ≤ Grade 1 or baseline (excluding alopecia).
- Note: Subjects with chronic, stable Grade 2 toxicities (defined as not worsening to ≥ Grade 2 for at least 3 months prior to enrollment and manageable with standard treatment) that are deemed by the investigator to be related to prior anti-cancer therapy may be included, e.g., chemotherapy-induced neuropathy or fatigue; residual toxicity from prior immunosuppressive therapy: Grade 1 or 2 endocrine disorders.
- Pregnant or lactating female patients, or patients planning pregnancy. Known history of severe hypersensitivity reaction to the active pharmaceutical ingredient (API), excipients in the drug formulation, or other monoclonal antibodies.
- History of another primary malignancy within 3 years, with the exception of adequately treated non-melanoma skin cancer, cured in situ disease, other cured solid tumors, or contralateral breast cancer.
- Substance abuse or any other medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the clinical study or the evaluation of the clinical study results, e.g., psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Cancer Hospital
Shanghai
Juan Jin Attending physician, 15996290233, medjinjuan@126.com
About this study
Official title: Study on Using HER2-PET to Predict the Efficacy of T-DXd Treatment in Advanced Breast Cancer and to Investigate the Heterogeneity of HER2 Expression
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 86 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.
- Conditions
- Breast Cancer Metastatic
- Being tested
- PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETOther
HER2-PET/CT and FDG-PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Advanced Breast Cancer | Not described Receives: Other: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative predictive value (NPV)
Negative Predictive Value of HER2 Expression as Assessed by HER2-PET for Objective Response.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start11 Nov 2024
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586215
- Sponsor's protocol ID
- PREDICT-HER
- Acronym
- PREDICT-HER
- Status last verified
- May 2026
- First submitted
- 26 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Using HER2-PET to Predict the Efficacy of T-DXd Treatment in Advanced Breast Cancer and to Investigate the Heterogeneity of HER2 Expression
- ClinicalTrials.gov ID
- NCT07586215
- Acronym / sponsor ID
- PREDICT-HER / PREDICT-HER
- Conditions
- Breast Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 86 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Breast Cancer | – | Other: PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced breast cancer patients
Key inclusion criteria (18 listed)
- Age ≥ 18 years.
- Histopathologically confirmed unresectable locally advanced or metastatic breast cancer, with documented prior immunohistochemistry (IHC) results indicating HER2-positive (IHC 3+, or IHC 2+ with positive FISH) or HER2-low (IHC 1+, or IHC 2+ with negative FISH) expression.
- For patients with hormone receptor-positive (HR+), HER2-negative breast cancer, patients must have received prior treatment with a CDK4/6 inhibitor in the locally advanced or metastatic setting, or experienced disease recurrence during adjuvant intensified CDK4/6 inhibitor therapy or within 12 months after completing adjuvant intensified CDK4/6 inhibitor therapy. (HR-positive is defined as ≥ 1% of tumor cells demonstrating positive ER staining by IHC; HER2-negative is defined as IHC score 0 or 1+, or IHC score 2+ with no evidence of in situ hybridization [ISH] gene amplification, or no evidence of ISH gene amplification in the absence of an IHC test.)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Documented radiological or objective evidence of disease progression on or after the most recent line of systemic therapy prior to initiating study treatment.
Key exclusion criteria (16 listed)
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, uncontrolled or significant cardiovascular disease, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroid treatment, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Patients who have used immunosuppressive agents within 14 days prior to the first dose of study drug, with the exception of those using intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose less than 10 mg/day prednisone or an equivalent dose.
- Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, significant pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disease with associated pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), and/or prior lung resection.
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 |
|---|---|---|
| PETHER2-PET/CT and FDG-PET/CT | Other | Advanced Breast Cancer |
Primary outcome
negative predictive value (NPV)
Time frame: through study completion, an average of 1 year
Negative Predictive Value of HER2 Expression as Assessed by HER2-PET for Objective Response.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic, run by Fudan University at 1 site in China.
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 18 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 10 Sep 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Jin Attending physician (15996290233, medjinjuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative predictive value (NPV) (time frame: through study completion, an average of 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 10 Sep 2026.