New study seeks to improve quality of life for advanced breast cancer patients
NCT ID NCT07551050
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tracks how patients with metastatic triple-negative breast cancer feel during treatment with sacituzumab govitecan or standard chemotherapy. Researchers will measure changes in quality of life and symptoms using patient questionnaires. The goal is to see which treatment helps patients live better, not just longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab govitecan
- What this could lead to
- If successful, this study could show that sacituzumab govitecan improves quality of life more than standard chemotherapy for people with metastatic triple-negative breast cancer.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. It only includes Chinese patients, so findings may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
TNBC
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged 18 to 75 years. 2. 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. 3. 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. 4. ECOG-PS ≤2 5. 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. 6. At least one evaluable lesion by CT or MRI according to RECIST 1.1. 7. Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances. 8. Willing to use contraceptive measures during the study period. 9. Willing and able to complete electronic questionnaires/scales on a smartphone, tablet, or other electronic device. 10. All patients can provide an informed consent before enrolment and data collection. Exclusion Criteria: 1. 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. 2. History of other malignancies or hematologic malignancies. 3. Hypersensitivity to the study treatment drugs. 4. Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration. 5. Treatment with an investigational product within 4 weeks before the first treatment. 6. Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration. 7. 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. 8. 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. 9. Pregnant or breastfeeding women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Real-World data match trial results for pembrolizumab in Triple-Negative breast cancer?
- Can a new pill outsmart mutant cancers?
- Can an immunotherapy combo boost tumor shrinkage in a common breast cancer?
- Can a new drug shrink Hard-to-Treat tumors?
- Can Gene-Edited immune cells tame Hard-to-Treat cancers?
- Can a One-Time Anti-Inflammatory shot during surgery curb Triple-Negative breast Cancer's return?