Actively Recruiting
A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-25
138
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years.
- Histologically confirmed triple-negative invasive breast cancer with ER < 10%, PR < 10%, and HER2 0-1+ or 2+ with negative FISH or CISH.
- Patients with locally advanced or metastatic breast cancer who had radical surgery and received 1 to 2 lines of chemotherapy in advanced treatment.
- Early-stage triple-negative breast cancer patients with disease progression within one year after neoadjuvant or adjuvant therapy.
- No prior use of immunotherapy or anti-angiogenic drugs.
- At least one measurable lesion based on RECIST 1.1.
- No contraindications to chemotherapy, immunotherapy, or anti-angiogenic therapy.
- Stable or asymptomatic brain metastases allowed.
- ECOG Performance Status score of 0 to 2 with predicted survival over 12 weeks.
- All acute toxicities from prior treatments resolved to Grade ≤1 (excluding alopecia).
- Women of childbearing potential must agree to medically approved contraception during treatment and for at least three months post-treatment.
- Adequate organ function meeting specified blood counts, liver, kidney, and heart function criteria.
- Voluntary enrollment with excellent adherence and active participation in safety and survival follow-up.
You will not qualify if you...
- Uncontrolled central nervous system metastases requiring treatment or symptomatic.
- Symptomatic third-space effusions not manageable by drainage or other interventions.
- Participation in another clinical trial within 30 days before enrollment.
- History of other malignancies within 5 years, except certain treated skin and cervical cancers.
- Uncontrolled cardiac conditions including heart failure NYHA class II or higher, unstable angina, recent myocardial infarction, significant arrhythmias, or QTc > 470 ms.
- Arterial or venous thrombotic events within 24 weeks before consent.
- History within 24 weeks of peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess.
- Conditions impairing oral drug absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Allergies or intolerance to sacituzumab govitecan, toripalimab, bevacizumab, or anlotinib.
- Active HIV infection, active hepatitis B or C infection.
- Pregnant or lactating women, women unwilling to use contraception during the trial.
- Concomitant diseases or conditions that may compromise safety, affect study results, or prevent study completion in the investigator's judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
C
Chunfang Hao, Associate chief physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here