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

NCT06797622 | Not Yet Recruiting Phase 2

• 1 other identifier: YOUNGBC-33
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Difference of baseline heterogeneity index

  Difference of baseline heterogeneity index evaluated by 68Ga-FAPI PET-CT between cerebral lesions reaching ORR or not with the T-DXd treatment.

  6 weeks

Secondary Outcomes (4)

• 68Ga-FAPI PET-CT value

  6 weeks

• Difference of baseline heterogeneity index

  6 weeks

• Difference of baseline heterogeneity index

  6 weeks

• 68Ga-FAPI PET-CT value

  6 weeks

Study Arms (1)

Trastuzumab deruxtecan (T-DXd)

EXPERIMENTAL

Trastuzumab deruxtecan (T-DXd)

Drug: Trastuzumab deruxtecan (T-DXd)

Interventions

Trastuzumab deruxtecan (T-DXd) DRUG

Trastuzumab deruxtecan (T-DXd)

Trastuzumab deruxtecan (T-DXd)

Eligibility Criteria

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

You may qualify if:

• Patients aged over 18 years old.
• ECOG 0-2.
• 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.
• 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.
• It is allowed to use mannitol, bevacizumab, or corticosteroids before enrollment, but dose should be stable for at least one week.
• Plan to receive Trastuzumab deruxtecan (T-DXd).
• Adequate bone marrow, liver, kidney and cardiac function.
• All patients can provide an informed consent before enrolment and data collection.

You may not qualify if:

• Leptomeningeal involvement.
• Uncontrolled large amount of pleural effusion and ascites.
• Previous treatment of T-DXd.
• 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.
• Patients with previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis require corticosteroids treatment; or any clinically active interstitial lung disease currently.
• Use of any investigational agent within 14 d before initiation of treatment.
• Concomitant other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid or anticancer hormonal treatment.
• 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.
• Clinically significant cardiac disease.
• Patients with known hypersensitivity to trastuzumab or 68Ga-FAPI.
• 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.
• Patients with the history of immunodeficiency, including HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• Patients with HBsAg positive and HBV \>=1000, HCV antibody positive, TP-Ab positive or HIV positive.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

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

Study Officials

• Biyun Wang, Profssor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biyun Wang, Professor

CONTACT

18017312387; wangbiyun0107@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 28, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)