Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer

Study Purpose

The purpose of this study was to explore the predictive value of the heterogeneity of 68Ga-FAPI PET-CT uptake before treatment on the response of T-DXd treatment in patients with brain metastases of HER2-positive breast cancer. The patient underwent 68Ga-FAPI PET-CT examinations within 2 weeks before and after 2 cycles of T-DXd treatment. Heterogeneity index, SUVmax, SUVmean and other uptake values were collected to investigate the association with efficacy of T-DXd.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients aged over 18 years old. 2. ECOG 0-2. 3. Patients have been diagnosed with unresectable, locally advanced or metastatic HER2-positive breast cancer, which were by means of immunohistochemical analysis (with 3+ indicating positive status), fluorescence in situ hybridization (with an amplification ratio ≥2.0 indicating positive status), or both. 4. Brain metastasis was confirmed by MRI; measurable disease as defined by at least one intracranial cerebral metastatic lesion with diameter ≥ 1.0 cm not previously treated with radiation. 5. It is allowed to use mannitol, bevacizumab, or corticosteroids before enrollment, but dose should be stable for at least one week. 6. Plan to receive Trastuzumab deruxtecan (T-DXd). 7. Adequate bone marrow, liver, kidney and cardiac function. 8. All patients can provide an informed consent before enrolment and data collection.

Exclusion Criteria:

1. Leptomeningeal involvement. 2. Uncontrolled large amount of pleural effusion and ascites. 3. Previous treatment of T-DXd. 4. Adequate treatment washout period before enrollment, defined as: major surgery ≥4 weeks, radiation therapy ≥4 weeks, chemotherapy ≥4 weeks, small-molecule targeted agents, anticancer hormonal therapy, antibody-based treatment ≥3 weeks. 5. Patients with previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis require corticosteroids treatment; or any clinically active interstitial lung disease currently. 6. Use of any investigational agent within 14 d before initiation of treatment. 7. Concomitant other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid or anticancer hormonal treatment. 8. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years, including contralateral breast cancer. 9. Clinically significant cardiac disease. 10. Patients with known hypersensitivity to trastuzumab or 68Ga-FAPI. 11. a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs. 12. Patients with the history of immunodeficiency, including HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 13. Patients with HBsAg positive and HBV >=1000, HCV antibody positive, TP-Ab positive or HIV positive. 14. Pregnant or lactating women. Women with childbearing potential must have a negative pregnancy test at screening; also excluded are women with childbearing potential, including women whose last menstrual period was <1 year before screening, unable or unwilling to use adequate contraception from study start to 1 year after the last dose of protocol therapy. Acceptable contraception methods included the application of an intrauterine device, barrier method or total abstinence.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06797622
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fudan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Biyun Wang, Profssor
Principal Investigator Affiliation Fudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, Metastatic Breast Cancer
Arms & Interventions

Arms

Experimental: Trastuzumab deruxtecan (T-DXd)

Trastuzumab deruxtecan (T-DXd)

Interventions

Drug: - Trastuzumab deruxtecan (T-DXd)

Trastuzumab deruxtecan (T-DXd)

Contact a Trial Team

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International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

Biyun Wang, Professor

[email protected]

18017312387

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