Breast cancer: test a new imaging method to guide ADC drug therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a noninvasive PET/CT imaging approach with 68Ga-TTP to visualize TROP2 expression in breast cancer lesions and to evaluate the response to ADC drug therapy. Participants receive imaging with 18F-FDG and 68Ga-TTP to characterize tumor biology and monitor treatment effect. Eligibility includes adults 18-75 with confirmed breast cancer, adequate organ function, and the ability to comply with follow-up, with precautions for pregnancy and contraception where applicable. The study is led by Peking University Cancer Hospital & Institute with collaboration from Yunnan Cancer Hospital, conducted at Beijing sites. Outcomes will inform whether this imaging strategy can guide ADC therapy decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
2. 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;
3. Patients with confirmed or suspected breast cancer;
4. Expected survival ≥12 weeks;
5. Good follow-up compliance;
6. 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;
7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Exclusion Criteria:

1. Severe abnormal liver and kidney function;
2. Pregnant, pregnant and lactating women;
3. Can not lie flat for half an hour;
4. Unable to obtain informed consent;
5. Suffering from claustrophobia or other mental illness;
6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
7. Other conditions deemed unsuitable for participation in the trial by the investigator.

Where it's running

• Peking University Cancer Hospital & Institute
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhi Yang
• Email: pekyz@163.com
• Phone: 010-88196196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.