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Breast Cancer MetastaticNCT07708922

Nectin-4 PET to Predict Response to Nectin-4-Targeted Therapy in Advanced Breast Cancer

An observational study of Breast Cancer Metastatic, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, single-arm, exploratory clinical trial that plans to enroll 40 patients with locally advanced or metastatic breast cancer who are expected to participate in a therapeutic clinical trial of a Nectin-4-targeted agent at our center and receive at least two treatment cycles. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Cancer Metastatic
How many people
40 participants
Where
1 siteChina
Study dates
30 Jun 2026to 30 Dec 2029
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: advanced breast cancer patients

Who may be able to join

  • 1. Age ≥18 years.
  • 2. Histopathologically confirmed unresectable locally advanced or metastatic breast cancer.
  • 3. The participant must be confirmed during screening to meet all inclusion and exclusion criteria for at least one of the following therapeutic clinical trials involving a Nectin-4-targeted agent being conducted at this center and must have signed the corresponding informed consent form:
  • Protocol BC-MUL-IIT-SHRA2102: *A Study of the Efficacy and Safety of SHR-A2102 in Patients With HR-Positive/HER2-Negative Advanced Breast Cancer Following Failure of a CDK4/6 Inhibitor Combined With Endocrine Therapy*;
  • Protocol SC-101-201: *A Phase IIa Clinical Study Evaluating the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification.*
  • Note:** Summaries of the study designs and eligibility criteria for these two clinical trials are provided in Appendix 1.
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  • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 5. Radiographic or objective evidence of disease progression during or after the most recent systemic therapy administered before initiation of the study treatment, or intolerance to toxicity associated with prior treatment.
  • 6. Life expectancy of ≥12 weeks at screening.
  • 7. At least one lesion that has not previously received radiotherapy and is accurately measurable at baseline by CT or MRI, with a longest diameter of ≥10 mm. For lymph nodes, the short-axis diameter must be ≥15 mm. For participants with bone-only disease, osteolytic or mixed osteolytic bone lesions evaluable by CT, MRI, or X-ray are acceptable.
  • 8. Left ventricular ejection fraction ≥50% within 28 days before randomization.
  • 9. Adequate organ and bone marrow function within 14 days before randomization. For all parameters listed below, the most recently obtained test results must meet the following eligibility criteria:
  • Hemoglobin ≥9 g/dL;
  • Absolute neutrophil count ≥1,500/mm³;
  • Platelet count ≥100,000/mm³;
  • At baseline, total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN) in the absence of liver metastases, or <3 × ULN in participants with Gilbert syndrome (unconjugated hyperbilirubinemia) or liver metastases;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN, or <5 × ULN in participants with liver metastases;
  • Serum albumin ≥2.5 g/dL;
  • Creatinine clearance ≥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.
  • 10. From screening throughout the study treatment period and for 7 months after the final dose of study treatment, female participants must not donate ova or retrieve ova for their own use. Breastfeeding must be avoided during this period. Participants wishing to preserve ova should consider doing so before randomization into this study.

Who cannot join

  • 1. Uncontrolled intercurrent illness, including but not limited to ongoing or active infection; uncontrolled or clinically significant cardiovascular disease; severe chronic gastrointestinal disease associated with diarrhea; or psychiatric or social conditions that may limit compliance with study requirements, substantially increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
  • 2. Uncontrolled or clinically significant cardiovascular disease, including any of the following:
  • A history of myocardial infarction or symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Class II-IV) within 6 months before randomization. Patients with troponin levels above the upper limit of normal (ULN), as defined by the manufacturer, at screening but without symptoms suggestive of myocardial infarction must undergo cardiology consultation before randomization to rule out myocardial infarction; b. Uncontrolled hypertension; c. Uncontrolled and/or clinically significant cardiac arrhythmia.
  • 3. Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.
  • 4. Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic disease or disease requiring corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive brain metastases may be enrolled. Patients who have received treatment for brain metastases may be included provided that they are asymptomatic, no longer require corticosteroids or anticonvulsants, and have recovered from the acute toxic effects of radiotherapy.
  • 5. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C infection. Among patients who test positive for hepatitis C antibodies, only those with negative hepatitis C virus RNA by polymerase chain reaction are eligible for enrollment.
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  • 6. Unresolved toxicity from prior anticancer therapy, defined as toxicity that has not recovered to Grade ≤1 or baseline, except for alopecia.
  • Note:** Patients with chronic, stable Grade 2 toxicities that, in the investigator's judgment, are related to prior anticancer therapy may be enrolled, provided that the toxicity has not worsened to Grade ≥2 for at least 3 months before enrollment and can be managed with standard treatment. Examples include chemotherapy-induced neuropathy or fatigue and residual toxicities from prior immunotherapy, such as Grade 1 or 2 endocrine disorders.
  • 7. Female patients who are pregnant or breastfeeding, or patients planning to become pregnant.
  • 8. Known history of severe hypersensitivity to the active pharmaceutical ingredient, any inactive component of the drug formulation, or other monoclonal antibodies.
  • 9. History of another primary malignancy within the previous 3 years, except for adequately resected non-melanoma skin cancer, cured carcinoma in situ, other cured solid tumors, or contralateral breast cancer.
  • 10. Substance abuse or any other medical condition, such as a psychiatric disorder, that, in the investigator's judgment, may interfere with the patient's participation in the clinical study or with the evaluation of study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan Cancer Hospital

    Shanghai

Other trials in China

About this study

This is a prospective, single-arm, exploratory clinical trial that plans to enroll 40 patients with locally advanced or metastatic breast cancer who are expected to participate in a therapeutic clinical trial of a Nectin-4-targeted agent at our center and receive at least two treatment cycles. All participants must meet the eligibility criteria of the therapeutic clinical trial in which they intend to participate and provide separate written informed consent for this study. The Nectin-4-targeted agents used in the two clinical trials currently underway at our center are provided to participants free of charge.

All participants must undergo an ^18F-FDG PET/CT scan and a complimentary ^68Ga-FZ-NR-1 PET/CT scan (Nectin-4 PET) within 28 days before initiating treatment with a Nectin-4-targeted agent. After completing the baseline assessments, participants will begin treatment in accordance with the protocol of the therapeutic clinical trial of the Nectin-4-targeted agent in which they are enrolled and will be followed according to the requirements of the corresponding protocol until disease progression, unacceptable toxicity, or withdrawal from the study.

Read more

Participants will be encouraged to undergo an additional complimentary Nectin-4 PET/CT scan after completion of the first treatment cycle and within 7 days before administration of the second treatment cycle to assess early changes in target expression during treatment.

Peripheral blood samples will be collected at baseline, before the first dose of Cycle 3, and at disease progression. Participants will also be encouraged to undergo needle biopsy of a metastatic lesion at baseline and at disease progression to explore potential mechanisms of resistance and other relevant biomarkers.

All PET/CT images will be independently reviewed by two physicians from the Department of Nuclear Medicine at our center who have extensive experience in diagnostic imaging.

What participants receive

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

Study groups in NCT07708922
Study groupRoleWhat they receive
Advanced Breast CancerNectin-4-PET/CT and FDG-PET/CT

What is being measured

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

  1. To evaluate the predictive value of baseline Nectin-4 expression assessed by Nectin-4 PET for the efficacy of Nectin-4-targeted therapy in patients with locally advanced or metastatic breast cancer.

    Correlation Between the Baseline Nectin-4 PET Maximum Standardized Uptake Value (SUVmax) and Objective Response Rate (ORR)

    Measured: Up to disease progression, 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.

  1. First posted16 Jul 2026
  2. Study start30 Jun 2026
  3. Primary completion30 Jul 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708922
Sponsor's protocol ID
2510-Exp292
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
16 Jul 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?

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 21 inclusion and 12 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 16 Jul 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?

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?

To evaluate the predictive value of baseline Nectin-4 expression assessed by Nectin-4 PET for the efficacy of Nectin-4-targeted therapy in patients with locally advanced or metastatic breast cancer. (time frame: Up to disease progression, 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?

On the ClinicalTrials.gov record for NCT07708922.

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 16 Jul 2026.

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