Breast Cancer InvasiveGzmB-PET4BCNCT06725940
GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
An observational study of Breast Cancer Invasive, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- 68Ga-GZMB PET/CT
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients receiving neoadjuvant treatment
Who may be able to join
- age 16-65
- histologically confirmed unilateral primary invasive breast cancer
- Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy
- complete clinical and histo-pathological information
- ECOG 0-1 within 10 days from the beginning of the study
- Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10^9/L, Neutrophil count ≥ 1.5×10^9/L, Hemoglobin level ≥ 90g/L; Platelet count (PLT) ≥ 80×10^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate > 50ml/min.
- The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form
Who cannot join
- bilateral or metastatic (stage IV) breast cancer
- There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infection or other uncontrolled diseases
- Patients with psychiatric disorders or those unable to comply with treatment due to other reasons
- Known allergy or intolerance to the drug or its excipients
- Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past
- Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.
- Patients deemed unsuitable for participation in this study by the investigator.
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, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, 200025
Xiaosong Chen, +86-21-64370045-602102, xiaosongchen0156@hotmail.com
Siji Zhu, +86-21-64370045-602102, zsj_mu@yeah.net
About this study
Official title: Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.
- Conditions
- Breast Cancer Invasive
- Being tested
- 68Ga-GZMB PET/CT
- Keywords
- breast cancer, Granzyme B, PET/CT, neoadjuvant treatment, pCR
- Medical subject headings
- Breast Neoplasms, Lipodystrophy, Congenital Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-GZMB PET/CTDevice
68Ga-GZMB PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patient receiving 68Ga-GZMB PET/CT Receives: Device: 68Ga-GZMB PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR
Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance
Measured: through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT
Measured: through study completion, an average of 1 year
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaosong Chen, Principal investigator, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725940
- Sponsor's protocol ID
- RJBC-GZMB
- Acronym
- GzmB-PET4BC
- Status last verified
- Dec 2024
- First submitted
- 24 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe
- ClinicalTrials.gov ID
- NCT06725940
- Acronym / sponsor ID
- GzmB-PET4BC / RJBC-GZMB
- Conditions
- Breast Cancer Invasive
- Keywords
- breast cancer, Granzyme B, PET/CT, neoadjuvant treatment, pCR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Device: 68Ga-GZMB PET/CTPatient receiving 68Ga-GZMB PET/CT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients receiving neoadjuvant treatment
Key inclusion criteria (7 listed)
- age 16-65
- histologically confirmed unilateral primary invasive breast cancer
- Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy
- complete clinical and histo-pathological information
- ECOG 0-1 within 10 days from the beginning of the study
Key exclusion criteria (8 listed)
- bilateral or metastatic (stage IV) breast cancer
- There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infection or other uncontrolled diseases
- Patients with psychiatric disorders or those unable to comply with treatment due to other reasons
- Known allergy or intolerance to the drug or its excipients
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 |
|---|---|---|
| 68Ga-GZMB PET/CT68Ga-GZMB PET/CT | Device | Study cohort |
Primary outcome
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
Time frame: through study completion, an average of 1 year
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer
3 secondary outcomes
Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR
Time frame: through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT
Time frame: through study completion, an average of 1 year
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes
Time frame: through study completion, an average of 1 year
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 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Xiaosong Chen principal investigator
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Invasive, run by Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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.
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 Xiaosong Chen (+86-21-64370045-602102, chenxiaosong0156@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR (time frame: through study completion, an average of 1 year). 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 10 Dec 2024.