Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New study seeks to improve quality of life for advanced breast cancer patients

NCT ID NCT07551050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HR+/HER2- breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.