PET/CT for Trop2 ADC Response Evaluation Cancers

NCT07046689 | Recruiting

• 1 other identifier: XMYY-2025KY102
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.

Conditions

Breast Cancer; Trop2; PET/CT

Keywords

Breast cancer; Trop2; PET/CT; Trop2-ADC

Outcome Measures

Primary Outcomes (1)

• The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy

  For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.

  2024.11-2026.6

Secondary Outcomes (1)

• Correlation Between PET Parameters and Survival

  2024.11-2026.12

Study Arms (1)

68Ga-MY6349 PET/CT

Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy.

Diagnostic Test: 68Ga-MY6349 PET/CT

Interventions

68Ga-MY6349 PET/CT DIAGNOSTIC_TEST

Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy.

68Ga-MY6349 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with previously treated metastatic breast cancer (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report).

You may qualify if:

• adult patients (aged 18 years or order)
• histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports
• presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
• willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee

You may not qualify if:

• Evidence of significantly impaired hepatic or renal function
• Estimated life expectancy of less than 3 months

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liang Zhao, phd

CONTACT

86 18818350620; wzhaoliang01@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 1, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)