Trop-2 Targeted PET Probes in Advanced TNBC

NCT07046455 | Recruiting

• 1 other identifier: Y-Gilead2024-PT-0099
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

According to inclusion and exclusion criteria, 20 eligible subjects with triple-negative breast cancer (TNBC) scheduled to receive sacituzumab govitecan were screened. Relevant examination results within 2 weeks before enrollment, including blood and urine routine tests, blood biochemistry, electrocardiogram, serum pregnancy test (for females only), imaging examinations, vital signs, and physical examinations, were collected as baseline assessments to determine whether subjects met enrollment requirements. After enrollment, subjects underwent 89Zr-DFO-hSR7 and 18F-FDG examinations at three time points: before sacituzumab govitecan treatment, after 2 cycles of treatment, and at disease progression. (Subjects first underwent 18F-FDG examination, followed by 89Zr-DFO-hSR7 examination within 1 week.) Within 2 years (with a 1-month window) after completing baseline examinations, investigators will conduct 3-5 follow-ups (at 1 month, 6 months, 1 year, 1.5 years, and 2 years post-examination) via medical record system review or telephone interviews to collect laboratory test results, pathological findings, comprehensive diagnostic results from other imaging modalities, and compare the efficacy of TROP-2 ADC therapy with the results of 89Zr-DFO-hSR7 and 18F-FDG examinations. This is an exploratory study, initially planned to enroll 20 cases. After obtaining preliminary sample data, further analysis will be conducted to calculate the required sample size. The radiation dose of the drug is approximately 0.02-0.03 mCi/kg. The quality standards for the formulation will be established in accordance with the Chinese Pharmacopoeia (2020 Edition).

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

Trop-2; PET probe; triple-negative breast cancer (TNBC)

Outcome Measures

Primary Outcomes (2)

• changes in SUV values

  SUV values of each tumor lesion in 89Zr-DFO-hSR7 PET/CT and 18F-FDG PET/CT imaging before and after sacituzumab govitecan treatment

  Enrollment up for approximately 36 months.

• Pathological biopsy results

  Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging.

  Enrollment up for approximately 36 months.

Secondary Outcomes (1)

• The tumor-to-background ratio (TBR)

  Enrollment up for approximately 36 months.

Study Arms (1)

PET-CT Probe+ Trop-2 ADC

EXPERIMENTAL

Drug: Sacituzumab Govitecan (SG)

Interventions

Sacituzumab Govitecan (SG) DRUG

After enrollment, before subjects receive TROP-2 ADC treatment, after 2 cycles of treatment, and at the time of progression, in these three phases, subjects will undergo 89Zr-DFO-hSR7 and 18F-FDG examinations once respectively (subjects will first undergo the 18F-FDG examination, and then the 89Zr-DFO-hSR7 examination within 1 week).

PET-CT Probe+ Trop-2 ADC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 75 years, male or female, with an ECOG score ≥ 2.
• Blood routine, liver and kidney functions meet the following standards:
• Blood routine: Total white blood cell count (WBC) ≥ 3.0×10⁹/L or neutrophil count (Neu) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 80×10⁹/L, hemoglobin (Hb) ≥ 80 g/L.
• Liver and kidney functions: Total bilirubin (T - Bil) ≤ 1.5×ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN or ≤ 5×ULN (in case of liver metastasis), serum creatinine (SCr) ≤ 1.5×ULN.
• Subjects with advanced triple - negative breast cancer previously diagnosed by histopathological diagnosis and imaging evaluation.
• Expected survival time ≥ 12 weeks.
• Clinicians assess that TROP - 2 ADC is an appropriate treatment plan for the subject at present.
• There is at least one measurable target lesion in accordance with the RECIST 1.1 standard.
• Subjects for whom clinicians recommend PET/CT examination for breast tumor diagnosis and staging.
• Women of childbearing age (18 - 60 years old) must undergo a pregnancy test within 7 days before the start of the examination and the result is negative; Male and female subjects with fertility must agree to use effective contraceptive measures to ensure no pregnancy during the study period and within 3 months after the examination.
• The subject can fully understand and voluntarily participate in this experiment, sign the informed consent form, and have good follow - up compliance.

You may not qualify if:

• Severe abnormalities in liver and kidney functions;
• Women who are in the pre - pregnancy period, pregnant or lactating;
• Those who cannot lie flat for half an hour;
• Those who cannot provide informed consent;
• Those suffering from claustrophobia or other mental illnesses;
• Those known to be allergic to the investigational drugs or their excipients used in the study treatment;
• Other situations that the researchers consider make it inappropriate to participate in the trial.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guohong Song, Doctor of Medicine (M.D.)

CONTACT

0086-88121122-2066; songguohong918@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 1, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

CN (1)