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New treatment option for Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced...
Official title A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06878625
What this study is testing
What is Sacituzumab Govitecan combined with Toripalimab?
Sacituzumab Govitecan combined with Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for evaluating the efficacy of trop-2 adc combination therapy in advanced triple-negative 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
- Research purposes: the research design in the late more than 2 lines TNBC prospective, multicenter, cohort study, respectively to observe Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) the efficacy and safety. Indications: Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) treat above 2 late three negative breast cancer (TNBC).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 30 months
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 70, women only
You may be able to join if
- Aged between 18 and 70 years.
- Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER \< 10%, PR \< 10%, HER2 0-1+ or HER2...
- Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two...
- No prior use of immunotherapy or anti-angiogenic drugs.
- At least one measurable lesion based on RECIST 1.1 criteria.
You likely can't join if
- Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
- Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other...
- Participation in another clinical trial within 30 days prior to enrollment;
- History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid...
- Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction...
- Arterial or venous thrombotic events within 24 weeks preceding informed consent, including cerebrovascular accidents (e.g., transient ischemic...
See the full eligibility criteria
- Aged between 18 and 70 years.
- Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER \< 10%, PR \< 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018...
- Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Early-stage...
- No prior use of immunotherapy or anti-angiogenic drugs.
- At least one measurable lesion based on RECIST 1.1 criteria.
- No contraindications to chemotherapy, immunotherapy, or anti-angiogenic therapy.
- Stable or asymptomatic brain metastases are permitted.
- ECOG Performance Status (PS) score of 0-2; predicted survival exceeding 12 weeks.
- All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 per protocol criteria (excluding alopecia) before screening.
- Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post-treatment.
- Adequate organ function, meeting the following criteria: Hemoglobin ≥90 g/L without transfusion within 14 days; Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L; Platelets ≥75×10\^9/L; Total Bilirubin ≤1.5×ULN; AST and ALT...
- Participants were voluntarily enrolled in this study, demonstrated excellent adherence, and actively participated in safety and survival follow-up assessments.
- Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
- Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions;
- Participation in another clinical trial within 30 days prior to enrollment;
- History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma;
- Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or...
- Arterial or venous thrombotic events within 24 weeks preceding informed consent, including cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and...
- Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease...
- Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Patients with a documented history of allergy may have potential hypersensitivity or intolerance to gozzatuzumab, toripalimab, bevacizumab, or anlotinib.
- Active infection with human immunodeficiency virus (HIV), active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
- Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
- Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin 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 study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin 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.