TNBC - Triple-Negative Breast CancerNCT07551050
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
An observational study of TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 15 Jun 2029
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: TNBC
Who may be able to join
- Patients aged 18 to 75 years.
- Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
- The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- ECOG-PS ≤2
- For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+/HER2- breast cancer: prior treatment with endocrine therapy and CDK4/6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.
- At least one evaluable lesion by CT or MRI according to RECIST 1.1.
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- Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.
- Willing to use contraceptive measures during the study period.
- Willing and able to complete electronic questionnaires/scales on a smartphone, tablet, or other electronic device.
- All patients can provide an informed consent before enrolment and data collection.
Who cannot join
- Insufficient bone marrow, hepatic, or renal function, defined as:
- Bone marrow: White blood cell count < 3.0 × 10⁹/L, or absolute neutrophil count < 1.5 × 10⁹/L, or platelet count < 75 × 10⁹/L, or hemoglobin < 8.0 g/dL.
- Hepatic function: Total bilirubin > 1.5 × upper limit of normal (ULN), or ALT/AST > 3.0 × ULN (or > 5.0 × ULN in the presence of liver metastases).
- Renal function: Serum creatinine > 1.5 × ULN, or creatinine clearance < 50 mL/min.
- History of other malignancies or hematologic malignancies.
- Hypersensitivity to the study treatment drugs.
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- Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
- Treatment with an investigational product within 4 weeks before the first treatment.
- Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.
- Systemic inflammatory diseases, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or active vasculitis.
- Severe psychiatric or neurological disorders, including but not limited to schizophrenia, depression, mania, Alzheimer's disease, myasthenia gravis, seizure disorders, or known conditions that may provoke seizures.
- Pregnant or breastfeeding women.
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 University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, +86 18017312387, pro_wangbiyun@163.com
About this study
Official title: A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Breast Cancer Progressing on First-line Treatment
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- Sacituzumab Govitecan, chemotherapy, metastatic breast cancer, TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan | Sacituzumab Govitecan | |
| Chemotherapy of the physician's choice | Chemotherapy of the physician's choice, including single-agent or combination chemotherapy regimens consisting of commonly used chemotherapeutic drugs for breast cancer, such as taxanes, anthracyclines, vinorelbine, gemcitabine, capecitabine, eribulin, and cisplatin/carboplatin. Combination with other targeted therapies, including immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) and bevacizumab, is also permitted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
Measured: 12 weeks
Secondary outcomes (5)
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.
Measured: 12 weeks
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.
Measured: 12 weeks
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.
Measured: 12 weeks
PFS
Progression free survival
Measured: 6 weeks
OS
Overall Survival
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 posted24 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551050
- Sponsor's protocol ID
- SCRPC-01
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Breast Cancer Progressing on First-line Treatment
- ClinicalTrials.gov ID
- NCT07551050
- Acronym / sponsor ID
- SCRPC-01
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- Sacituzumab Govitecan, chemotherapy, metastatic breast cancer, TNBC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 24 Apr 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.
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan | – | –Sacituzumab Govitecan |
| Chemotherapy of the physician's choice | – | –Chemotherapy of the physician's choice, including single-agent or combination chemotherapy regimens consisting of commonly used chemotherapeutic drugs for breast cancer, such as taxanes, anthracyclines, vinorelbine, gemcitabine, capecitabine, eribulin, and cisplatin/carboplatin. Combination with other targeted therapies, including immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) and bevacizumab, is also permitted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TNBC
Key inclusion criteria (10 listed)
- Patients aged 18 to 75 years.
- Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
- The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- ECOG-PS ≤2
- For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+/HER2- breast cancer: prior treatment with endocrine therapy and CDK4/6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.
Key exclusion criteria (12 listed)
- Insufficient bone marrow, hepatic, or renal function, defined as:
- History of other malignancies or hematologic malignancies.
- Hypersensitivity to the study treatment drugs.
- Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
- Treatment with an investigational product within 4 weeks before the first treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
Time frame: 12 weeks
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
5 secondary outcomes
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.
Time frame: 12 weeks
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.
Time frame: 12 weeks
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.
Time frame: 12 weeks
PFS
Time frame: 6 weeks
OS
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 24 Apr 2026.
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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 TNBC - Triple-Negative 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 10 inclusion and 12 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 24 Apr 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 Biyun Wang Professor (+86 13701748410, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score. (time frame: 12 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 24 Apr 2026.