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New treatment option for Metastatic Breast Cancer
Official title Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
ClinicalTrials.gov ID: NCT06081959
What this study is testing
What is SKB264?
SKB264 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological...
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
- Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
You likely can't join if
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
- Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the...
- Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
- Uncontrollable systemic diseases assessed by the investigator;
- History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious...
- Clinically serious lung injuries caused by lung diseases;
See the full eligibility criteria
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
- Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Expected survival ≥ 12 weeks;
- Adequate organ and bone marrow function;
- Patients who are eligible for a chemotherapy regimen in the control group;
- Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the...
- Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
- Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
- Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
- Uncontrollable systemic diseases assessed by the investigator;
- History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be...
- Clinically serious lung injuries caused by lung diseases;
- Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding;
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
- Active hepatitis B or hepatitis C;
- Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection;
- Known allergy or hypersensitivity to SKB264, or the excipients of SKB264;
- Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy;
- Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
- Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment;
- Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.