Breast CancerPhase 2NCT06797622
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
A Phase 2 study testing Trastuzumab deruxtecan (T-DXd) in people with Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Trastuzumab deruxtecan (T-DXd)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 15 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, Professor, 18017312387, wangbiyun0107@hotmail.com
About this study
Official title: An Open-label Positron Emission Tomography (PET) Study to Investigate the Heterogeneity of 68Ga-FAPI Uptake Predicting the Response of T-DXd Treatment for Brain Metastasis in Patients with HER2-positive Advanced or Metastatic Breast Cancer.
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
- Being tested
- Trastuzumab deruxtecan (T-DXd)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecan (T-DXd)Drug
Trastuzumab deruxtecan (T-DXd)
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | Experimental | Trastuzumab deruxtecan (T-DXd) Receives: Drug: Trastuzumab deruxtecan (T-DXd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
68Ga-FAPI PET-CT value
68Ga-FAPI PET-CT value changes (SUVmax, SUVmean ) at baseline and 2 cycles after T-DXd treatment of brain metastasis lesions.
Measured: 6 weeks
Difference of baseline heterogeneity index
Difference of baseline heterogeneity index evaluated by 68Ga-FAPI PET-CT for PFS, CBR and OS in patients with brain metastasis after the T-DXd treatment.
Measured: 6 weeks
Difference of baseline heterogeneity index
Difference of baseline heterogeneity index, SUVmax and SUVmean evaluated by 68Ga-FAPI PET-CT between active or stable brain metastasis.
Measured: 6 weeks
68Ga-FAPI PET-CT value
68Ga-FAPI PET-CT value changes (heterogeneity index, SUVmax, SUVmean ) at baseline and 2 cycles after T-DXd treatment of whole body metastasis lesions.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, Profssor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797622
- Sponsor's protocol ID
- YOUNGBC-33
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Positron Emission Tomography (PET) Study to Investigate the Heterogeneity of 68Ga-FAPI Uptake Predicting the Response of T-DXd Treatment for Brain Metastasis in Patients with HER2-positive Advanced or Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT06797622
- Acronym / sponsor ID
- YOUNGBC-33
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | Experimental | Drug: Trastuzumab deruxtecan (T-DXd)Trastuzumab deruxtecan (T-DXd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecan (T-DXd)Trastuzumab deruxtecan (T-DXd) | Drug | Trastuzumab deruxtecan (T-DXd) |
Primary outcome
Difference of baseline heterogeneity index
Time frame: 6 weeks
Difference of baseline heterogeneity index evaluated by 68Ga-FAPI PET-CT between cerebral lesions reaching ORR or not with the T-DXd treatment.
4 secondary outcomes
68Ga-FAPI PET-CT value
Time frame: 6 weeks
Difference of baseline heterogeneity index
Time frame: 6 weeks
Difference of baseline heterogeneity index
Time frame: 6 weeks
68Ga-FAPI PET-CT value
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biyun Wang, Profssor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab deruxtecan (T-DXd) in people with Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biyun Wang, Professor (18017312387, wangbiyun0107@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of baseline heterogeneity index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.