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Breast CancerPhase 2NCT07419867

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

A Phase 2 study testing Chemotherapy plus dual-target therapy, Treatment including HER2 ADC and Treatment including immunotherapy in people with Breast Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Chemotherapy plus dual-target therapy, Treatment including HER2 ADC and Treatment including immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
1 Mar 2026to 1 Jan 2032
Phase
Phase 2
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18 to 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically confirmed invasive breast cancer.
  • Known ER, PR and HER2 status.
  • At least one measurable lesion according to RECIST 1.1.
  • Adequate organ function, meeting all of the following:
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  • 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).
  • Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan.
  • 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).
  • The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up.

Who cannot join

  • Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer.
  • Diabetics or those allergic to radionuclides who are not suitable for 18F-FDG PET/MR examination.
  • 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.
  • 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).
  • Major surgery within 4 weeks prior to randomization without full recovery, or an anticipated need for major surgery during study treatment.
  • 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.
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  • Severe and uncontrolled infection or known HIV infection.
  • Active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment) or fungal infection.
  • Pregnant or breastfeeding.
  • Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Known abuse of psychotropic substances, alcoholism, or drug abuse.
  • Known, definite neurological or psychiatric disorders associated with poor compliance, including but not limited to epilepsy or dementia.
  • 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.
  • Receiving radiotherapy (except for palliative reasons), chemotherapy and immunotherapy within 3 weeks before treatment, excluding bisphosphonates (can be used for bone metastasis).

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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhimin Shao, +86-021-64175590, zhimingshao@yahoo.com

Other trials in China

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
Chemotherapy plus dual-target therapy, Treatment including HER2 ADC, Treatment including immunotherapy, Treatment including Nectin-4 ADC, Treatment including Trop-2 ADC
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy plus dual-target therapyDiagnostic test

    Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.

  • Treatment including HER2 ADCDiagnostic test

    Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.

  • Treatment including immunotherapyDiagnostic test

    Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2.

  • Treatment including Nectin-4 ADCDiagnostic test

    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.

  • Treatment including Trop-2 ADCDiagnostic test

    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.

  • Treatment including CDK4/6 inhibitorDiagnostic test

    Drug: Treatment including CDK4/6 inhibitor. Procedure: 18F-FDG PET/MRI and CDKi PET/MRI will be performed at baseline and after cycle 2.

Study groups in NCT07419867
Study groupRoleWhat they receive
N1ExperimentalIf patients are HER2+ breast cancer receiving neoadjuvant therapy
Receives: Diagnostic Test: Chemotherapy plus dual-target therapy
N2ExperimentalIf patients are HER2+ breast cancer receiving neoadjuvant therapy
Receives: Diagnostic Test: Treatment including HER2 ADC
N3ExperimentalIf patients are TNBC receiving neoadjuvant therapy
Receives: Diagnostic Test: Treatment including immunotherapy
N4ExperimentalIf patients are breast cancer receiving neoadjuvant therapy
Receives: Diagnostic Test: Treatment including Nectin-4 ADC
A1ExperimentalIf patients are HER2+ breast cancer receiving salvage therapy
Receives: Diagnostic Test: Chemotherapy plus dual-target therapy
A2ExperimentalIf patients are HER2+ breast cancer receiving salvage therapy
Receives: Diagnostic Test: Treatment including HER2 ADC
A3ExperimentalIf patients are TNBC receiving salvage therapy
Receives: Diagnostic Test: Treatment including immunotherapy
A4ExperimentalIf patients are breast cancer receiving salvage therapy
Receives: Diagnostic Test: Treatment including Nectin-4 ADC
A5ExperimentalIf patients are breast cancer receiving salvage therapy
Receives: Diagnostic Test: Treatment including Trop-2 ADC
A6ExperimentalIf patients are HR+/HER2- breast cancer receiving salvage therapy
Receives: Diagnostic Test: Treatment including CDK4/6 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The correlation between specific tracer PET/MRI-related indicators and the efficacy of systemic treatment

    Change in PET/MRI-related indicators such as SUVmax from baseline to cycle 2 on in correlation with efficacy of systemic treatment.

    Measured: through study completion, an average of 24 weeks

Secondary outcomes (5)

  1. Event-free suvival (EFS)

    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.

    Measured: Three-year post-surgery follow-up

  2. Progression-free survival (PFS)

    Defined as the time period from the start of enrollment until any recorded disease progression or any cause of death.

    Measured: Three-year post-surgery follow-up

  3. Overall survival (OS)

    Defined as the time period from the start of enrollment until any cause of death.

    Measured: Three-year post-surgery follow-up

  4. CTCAE scale (V6.0)

    To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V6.0)

    Measured: Up to one year during follow-up

  5. Exploration of translational research markers

    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.

    Measured: Up to one year during follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2032 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07419867
Sponsor's protocol ID
SCHBCC-N0110
Status last verified
Feb 2026
First submitted
5 Feb 2026
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy plus dual-target therapy, Treatment including HER2 ADC and Treatment including immunotherapy in people with Breast Cancer, 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 17 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Feb 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.

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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07419867.

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 19 Feb 2026; AzTrials last refreshed its copy on 5 Nov 2026.

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