A Platform Study Based on Specific Tracer for Evaluating the Therapeutic Efficacy of Systemic Treatment for Breast Cancer Using PET/MRI

February 12, 2026 updated by: Zhimin Shao, Fudan University

A Platform Study Based on Specific Tracer for Evaluating the Therapeutic Efficacy of Systemic Treatment for Breast Cancer Using PET/MRI (A Prospective, Open-label, Phase II Platform Trial)

This study is a prospective, open-label, phase II clinical trial, aiming to explore the predictive effect of different specific tracers on the effectiveness of various systemic treatments for breast cancer. The unique feature of this study is that it is a platform study. The research cohort can be updated accordingly as specific tracers for PET/MRI and systemic treatment regimens for breast cancer are updated. The study will be divided into two treatment cohorts: neoadjuvant therapy and salvage therapy. The research cohort will be further subdivided based on specific treatment regimens and specific tracers for PET/MRI. The subjects will undergo one 18F-FDG PET/MRI and specific tracer PET/MRI examination at baseline (before treatment) and after 2 treatment courses. This study is an exploratory phase II clinical trial, and its main purpose is to screen valuable cohorts for subsequent larger-sample randomized controlled III-phase clinical studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged 18 to 70 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  3. Histologically confirmed invasive breast cancer.
  4. Known ER, PR and HER2 status.
  5. At least one measurable lesion according to RECIST 1.1.

  6. Adequate organ function, meeting all of the following:

    • Hemoglobin (Hb)≥90 g/L;
    • Absolute neutrophil count (ANC)≥1.5×10^9/L;
    • Platelet count (PLT)≥100×10^9/L;
    • Total bilirubin (TBIL)≤1.5×the upper limit of normal (ULN);
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN;
    • Alkaline phosphatase (ALP)≤2.5×ULN;
    • Serum creatinine (Cr)≤1.5×ULN;
    • Prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN, and international normalized ratio (INR)≤1.5×ULN (in patients not receiving anticoagulation).
  7. Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan.
  8. Women of childbearing potential must have a negative serum pregnancy test. Such patients must use a medically acceptable method of contraception during study treatment and for at least 6 months after the last dose of the study drug(s).
  9. The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up.

Exclusion Criteria:

  1. Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer.
  2. Diabetics or those allergic to radionuclides who are not suitable for 18F-FDG PET/MR examination.
  3. Serious cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to congestive heart failure, unstable angina, severe arrhythmias uncontrolled by medication, severe conduction abnormalities or clinically significant valvular disease, uncontrolled severe hypertension, myocardial infarction, or cerebrovascular accident.
  4. Any serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  5. Major surgery within 4 weeks prior to randomization without full recovery, or an anticipated need for major surgery during study treatment.
  6. Known active liver disease, including but not limited to active hepatitis B (defined as HBsAg positive with HBV-DNA≥1000 IU/mL), hepatitis C (defined as HCV-Ab positive with HCV-RNA above the assay's lower limit of quantification), or autoimmune liver disease.
  7. Severe and uncontrolled infection or known HIV infection.
  8. Active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment) or fungal infection.
  9. Pregnant or breastfeeding.
  10. Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
  11. Known abuse of psychotropic substances, alcoholism, or drug abuse.
  12. Known, definite neurological or psychiatric disorders associated with poor compliance, including but not limited to epilepsy or dementia.
  13. Any other serious physical or mental illness or laboratory abnormality that may increase the risk of study participation or interfere with study treatment and outcomes, or any other condition that, in the investigator's judgment, makes the patient unsuitable for this study.
  14. Receiving radiotherapy (except for palliative reasons), chemotherapy and immunotherapy within 3 weeks before treatment, excluding bisphosphonates (can be used for bone metastasis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: N1
If patients are HER2+ breast cancer receiving neoadjuvant therapy
Diagnostic test: Chemotherapy plus dual-target therapy
Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Experimental: N2
If patients are HER2+ breast cancer receiving neoadjuvant therapy
Diagnostic test: Treatment including HER2 ADC
Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Experimental: N3
If patients are TNBC receiving neoadjuvant therapy
Diagnostic test: Treatment including immunotherapy
Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2.
Experimental: N4
If patients are breast cancer receiving neoadjuvant therapy
Diagnostic test: Treatment including Nectin-4 ADC
Drug: Treatment including Nectin-4 ADC. Procedure: 18F-FDG PET/MRI and Nectin-4 PET/MRI will be performed at baseline and after cycle 2.
Experimental: A1
If patients are HER2+ breast cancer receiving salvage therapy
Diagnostic test: Chemotherapy plus dual-target therapy
Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Experimental: A2
If patients are HER2+ breast cancer receiving salvage therapy
Diagnostic test: Treatment including HER2 ADC
Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Experimental: A3
If patients are TNBC receiving salvage therapy
Diagnostic test: Treatment including immunotherapy
Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2.
Experimental: A4
If patients are breast cancer receiving salvage therapy
Diagnostic test: Treatment including Nectin-4 ADC
Drug: Treatment including Nectin-4 ADC. Procedure: 18F-FDG PET/MRI and Nectin-4 PET/MRI will be performed at baseline and after cycle 2.
Experimental: A5
If patients are breast cancer receiving salvage therapy
Diagnostic test: Treatment including Trop-2 ADC
Drug: Treatment including Trop-2 ADC. Procedure: 18F-FDG PET/MRI and Trop-2 PET/MRI will be performed at baseline and after cycle 2.
Experimental: A6
If patients are HR+/HER2- breast cancer receiving salvage therapy
Diagnostic test: Treatment including CDK4/6 inhibitor
Drug: Treatment including CDK4/6 inhibitor. Procedure: 18F-FDG PET/MRI and CDKi PET/MRI will be performed at baseline and after cycle 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correlation between specific tracer PET/MRI-related indicators and the efficacy of systemic treatment
Time Frame: through study completion, an average of 24 weeks
Change in PET/MRI-related indicators such as SUVmax from baseline to cycle 2 on in correlation with efficacy of systemic treatment.
through study completion, an average of 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event-free suvival (EFS)
Time Frame: Three-year post-surgery follow-up
Defined as the time period from the start of enrollment until the first occurrence of the relevant events. The relevant events include disease progression, disease recurrence and metastasis, contralateral invasive breast cancer, second primary invasive cancer, and any cause of death.
Three-year post-surgery follow-up
Progression-free survival (PFS)
Time Frame: Three-year post-surgery follow-up
Defined as the time period from the start of enrollment until any recorded disease progression or any cause of death.
Three-year post-surgery follow-up
Overall survival (OS)
Time Frame: Three-year post-surgery follow-up
Defined as the time period from the start of enrollment until any cause of death.
Three-year post-surgery follow-up
CTCAE scale (V6.0)
Time Frame: Up to one year during follow-up
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V6.0)
Up to one year during follow-up
Exploration of translational research markers
Time Frame: Up to one year during follow-up
The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers. The correlations between discovered biomarkers and subjects' disease status and treatment responses will also be investigated.
Up to one year during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCHBCC-N0110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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