Triple Negative Breast CancerNCT07705438
Granzyme B-PET: Predicting Immunotherapy Efficacy in TNBC
An observational study of Triple Negative Breast Cancer and Immune Checkpoint Inhibitor, run by Fudan University at 1 site in China.
Trial summary
This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI). All ICI treatments must be administered in accordance with current clinical indications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Immune Checkpoint Inhibitor, Granzyme B PET/CT
- What is being tested?
- [68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2025to 28 May 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced or metastatic triple-negative breast cancer patients scheduled to receive at least two cycles of an immune checkpoint inhibitor (ICI)-containing regimen
Who may be able to join
- Age ≥ 18 years.
- Histologically confirmed unresectable locally advanced or metastatic breast cancer, with immunohistochemistry (IHC) results indicating negativity for ER, PR, and Her-2. If pathology from a metastatic lesion is available, its histology will take precedence.
- ER and PR negativity is defined as: ER <1% positive and PR <1% positive, OR ER <10% with weak positivity and PR <10% with weak positivity.
- Her-2 negativity is defined as: an IHC score of 0 or 1+; or an IHC score of 2+ with a negative FISH test result. For patients with an IHC score of 0 or 1+, a FISH test is optional but must be negative if performed.
- Decision by the clinician to treat with a regimen containing an immune checkpoint inhibitor (ICI), with the patient scheduled to receive at least 2 cycles of treatment.
- 3.1. If the patient intends to participate in an ongoing clinical trial involving an ICI at our department, they must meet the inclusion and exclusion criteria of that specific trial. ICIs involved in clinical trials at our department include, but are not limited to, Pembrolizumab, Sintilimab, Toripalimab, and QL1706.
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- 3.2. For patients not enrolled in a clinical trial, they must have PD-L1 positive status (CPS ≥ 1), and the intended drug must be Toripalimab, as approved by the National Medical Products Administration (NMPA).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Evidence of radiological or objective disease progression during or after the most recent systemic therapy prior to study entry, or intolerance to the toxicity of prior treatment.
- Life expectancy of ≥ 12 weeks at the time of screening.
- Presence of at least one measurable lesion that has not been previously irradiated. The lesion must have a longest diameter of ≥10 mm at baseline as measured by CT or MRI (for lymph nodes, the short axis must be ≥15 mm). In cases where only bone lesions are present, lytic or mixed lytic-blastic bone lesions that can be assessed by CT, MRI, or X-ray are acceptable.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to randomization.
- Adequate organ and bone marrow function within 14 days prior to randomization. The most recently obtained results for all parameters listed below must be used to meet the eligibility criteria:
- Hemoglobin ≥ 9 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- At baseline, Total Bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases are present, or < 3 × ULN for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases.
- ALT and AST ≤ 3 × ULN, or < 5 × ULN for patients with liver metastases.
- Serum albumin ≥ 2.5 g/dL
- Creatinine clearance ≥ 30 mL/min (calculated using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) or Prothrombin Time (PT), and Partial Thromboplastin Time (PTT) or activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN.
- From the screening period through the entire study treatment period and for 7 months after the last dose of study treatment, female patients must not donate or retrieve oocytes (eggs) for personal use. Breastfeeding must be avoided during this period. If oocyte preservation is desired, it should be completed prior to randomization in this study.
Who cannot join
- Uncontrolled concomitant diseases, including but not limited to: persistent or active infection; uncontrolled or significant cardiovascular disease; severe chronic gastrointestinal conditions associated with diarrhea; or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction or symptomatic Congestive Heart Failure (CHF) (New York Heart Association [NYHA] Class II to IV) within 6 months prior to randomization. Patients with troponin levels above the upper limit of normal (ULN) (as defined by the manufacturer) at screening without any symptoms related to myocardial infarction should undergo a cardiology consultation prior to randomization to rule out myocardial infarction.
- Uncontrolled hypertension.
- Uncontrolled and/or clinically significant arrhythmias.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroid treatment, current ILD/pneumonitis, or suspected ILD/pneumonitis on imaging at screening that cannot be ruled out.
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- Use of immunosuppressive medications within 14 days prior to the first dose of the study drug, with the exception of intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose of less than 10 mg/day of prednisone or its equivalent.
- Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe Chronic Obstructive Pulmonary Disease [COPD], restrictive lung disease, significant pleural effusion), and/or any autoimmune, connective tissue, or inflammatory diseases with concomitant pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), and/or prior lung resection.
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals.
- Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be eligible. Subjects may be included if their brain metastases have been treated, they are no longer symptomatic, do not require corticosteroids or anticonvulsants, and have recovered from the acute toxic effects of radiotherapy.
- Active primary immunodeficiency, known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B or Hepatitis C infection. For patients with positive Hepatitis C antibody, only those who are negative for HCV RNA by polymerase chain reaction (PCR) are eligible for enrollment.
- Unresolved toxicity from prior anticancer therapy, defined as toxicity that has not resolved to ≤ Grade 1 or baseline (with the exception of alopecia).
- Note: Subjects with chronic, stable Grade 2 toxicity (defined as not having worsened for at least 3 months prior to enrollment and being manageable with standard therapy) that the investigator deems related to prior anticancer therapy may be enrolled. Examples include chemotherapy-induced neuropathy or fatigue; residual toxicity from prior immunosuppressive therapy such as Grade 1 or 2 endocrinopathy.
- Female patients who are pregnant or breastfeeding, or are planning to become pregnant.
- Known history of severe hypersensitivity reaction to the active substance, excipients in the drug formulation, or other monoclonal antibodies.
- History of another primary malignancy within the last 3 years, with the exception of: adequately resected non-melanoma skin cancer, curatively treated carcinoma in-situ, other solid tumors that have been cured, or contralateral breast cancer.
- Substance abuse or any other medical condition, such as a psychiatric illness, that in the investigator's judgment could interfere with the patient's participation in or the evaluation of the results of the clinical study.
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
Fudan Cancer Hospital
Shanghai
Juan Jin, Attending physician, 15996290233, medjinjuan@126.com
About this study
Official title: Study on Using Granzyme B-PET Imaging to Predict the Efficacy of Immunotherapy in Locally Advanced and Metastatic Triple-Negative Breast Cancer
This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI). All ICI treatments must be administered in accordance with current clinical indications. For patients who intend to participate in a clinical trial involving an ICI, they must meet the eligibility criteria of that specific trial protocol.
After screening and enrollment, participants will undergo a [68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT) scan before initiating the ICI-containing regimen and again after Cycle 2 (C2). Participants will continue the ICI regimen until disease progression, with tissue biopsies performed as needed.
By integrating patients' baseline clinical characteristics, treatment outcomes, and prognostic information, this study aims to conduct a comprehensive analysis. The objective is to investigate whether the following factors, as assessed by Granzyme B PET/CT, can serve as early predictors of response to immunotherapy in patients with advanced breast cancer: baseline Granzyme B expression levels, immunotherapy-activated Granzyme B levels after C2, and the heterogeneity of Granzyme B expression at baseline and after C2.
- Being tested
- [68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)Other
Granzyme B is a highly specific cytotoxic molecule. By binding to Granzyme B, Granzyme B-PET can visualize the distribution and activity of this enzyme within the tumor microenvironment on PET images. Performing Granzyme B-PET scans before and after immunotherapy allows for the monitoring of changes in active intratumoral immune cells during treatment. This, in turn, helps to assess whether the therapy has effectively activated the immune system and the extent of tumor cell killing. Granzyme B-PET images provide a measure of intratumoral Granzyme B uptake, thereby enabling an objective evaluation of the cytotoxic capacity of immune cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV)
Positive Predictive Value of Granzyme B Expression as Assessed by Granzyme B PET/CT for Objective Response.
Measured: Up to disease progression, 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 posted15 Jul 2026
- Study start28 May 2025
- Primary completion28 May 2027 (estimated)
- Study completion28 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705438
- Sponsor's protocol ID
- 250-Exp134-250
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Using Granzyme B-PET Imaging to Predict the Efficacy of Immunotherapy in Locally Advanced and Metastatic Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07705438
- Acronym / sponsor ID
- 250-Exp134-250
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 15 Jul 2026 (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.
This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI). All ICI treatments must be administered in accordance with current clinical indications. For patients who intend to participate in a clinical trial involving an ICI, they must meet the eligibility criteria of that specific trial protocol.
After screening and enrollment, participants will undergo a [68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT) scan before initiating the ICI-containing regimen and again after Cycle 2 (C2). Participants will continue the ICI regimen until disease progression, with tissue biopsies performed as needed.
By integrating patients' baseline clinical characteristics, treatment outcomes, and prognostic information, this study aims to conduct a comprehensive analysis. The objective is to investigate whether the following factors, as assessed by Granzyme B PET/CT, can serve as early predictors of response to immunotherapy in patients with advanced breast cancer: baseline Granzyme B expression levels, immunotherapy-activated Granzyme B levels after C2, and the heterogeneity of Granzyme B expression at baseline and after C2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic triple-negative breast cancer patients scheduled to receive at least two cycles of an immune checkpoint inhibitor (ICI)-containing regimen
Key inclusion criteria (22 listed)
- Age ≥ 18 years.
- Histologically confirmed unresectable locally advanced or metastatic breast cancer, with immunohistochemistry (IHC) results indicating negativity for ER, PR, and Her-2. If pathology from a metastatic lesion is available, its histology will take precedence.
- ER and PR negativity is defined as: ER <1% positive and PR <1% positive, OR ER <10% with weak positivity and PR <10% with weak positivity.
- Her-2 negativity is defined as: an IHC score of 0 or 1+; or an IHC score of 2+ with a negative FISH test result. For patients with an IHC score of 0 or 1+, a FISH test is optional but must be negative if performed.
- Decision by the clinician to treat with a regimen containing an immune checkpoint inhibitor (ICI), with the patient scheduled to receive at least 2 cycles of treatment.
Key exclusion criteria (17 listed)
- Uncontrolled concomitant diseases, including but not limited to: persistent or active infection; uncontrolled or significant cardiovascular disease; severe chronic gastrointestinal conditions associated with diarrhea; or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroid treatment, current ILD/pneumonitis, or suspected ILD/pneumonitis on imaging at screening that cannot be ruled out.
- Use of immunosuppressive medications within 14 days prior to the first dose of the study drug, with the exception of intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose of less than 10 mg/day of prednisone or its equivalent.
- Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe Chronic Obstructive Pulmonary Disease [COPD], restrictive lung disease, significant pleural effusion), and/or any autoimmune, connective tissue, or inflammatory diseases with concomitant pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), and/or prior lung resection.
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]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)Granzyme B is a highly specific cytotoxic molecule. By binding to Granzyme B, Granzyme B-PET can visualize the distribution and activity of this enzyme within the tumor microenvironment on PET images. Performing Granzyme B-PET scans before and after immunotherapy allows for the monitoring of changes in active intratumoral immune cells during treatment. This, in turn, helps to assess whether the therapy has effectively activated the immune system and the extent of tumor cell killing. Granzyme B-PET images provide a measure of intratumoral Granzyme B uptake, thereby enabling an objective evaluation of the cytotoxic capacity of immune cells. | Other | – |
Primary outcome
Positive Predictive Value (PPV)
Time frame: Up to disease progression, an average of 1 year
Positive Predictive Value of Granzyme B Expression as Assessed by Granzyme B PET/CT for Objective Response.
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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Triple Negative Breast Cancer and Immune Checkpoint Inhibitor, 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 22 inclusion and 17 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 15 Jul 2026. 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 Juan Jin, Attending physician (15996290233, medjinjuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) (time frame: Up to disease progression, 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 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.