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Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);

• Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;

• Patients with confirmed or suspected breast cancer;

• Expected survival ≥12 weeks;

• Good follow-up compliance;

• Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;

• Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Locations
Other Locations
China
Peking University Cancer Hospital & Institute
RECRUITING
Beijing
Contact Information
Primary
Zhi Yang
pekyz@163.com
010-88196196
Backup
Guojun Zhang
zhangguojun@kmmu.edu.cn;
0871-68231187
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: Diagnostic Validation Cohort
Patients with newly diagnosed or suspected breast cancer will undergo one \[68Ga\]Ga-TTP scan and one \[18F\]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with \[18F\]FDG, and correlate imaging findings with pathology and TROP2 expression.
Experimental: ADC Response Assessment Cohort
Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired \[68Ga\]Ga-TTP and \[18F\]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response.
Related Therapeutic Areas
Sponsors
Collaborators: Yunnan Cancer Hospital
Leads: Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov