Actively Recruiting
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
Led by Fudan University · Updated on 2024-02-08
338
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
CONDITIONS
Official Title
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Histologically confirmed HR-positive/HER2-negative invasive breast cancer
- SNF2 subtype confirmed by pathology at Fudan University Affiliated Cancer Hospital
- Locally advanced breast cancer not eligible for radical local treatment or recurrent metastatic breast cancer
- Measurable disease by RECIST v1.1 or unmeasurable lytic or mixed bone lesions without measurable lesions
- Adequate bone marrow function: neutrophils > 1.5x10⁹/L, platelets > 75x10⁹/L, hemoglobin > 9g/dL
- No previous chemotherapy or targeted therapy for metastatic disease
- Adequate liver and kidney function
- ECOG performance status ≤ 2 and life expectancy ≥ 3 months
- Voluntary participation with signed informed consent and agreement to follow-up
You will not qualify if you...
- Treatment with chemotherapy, radiotherapy, immunotherapy, or surgery (excluding outpatient surgery) for metastatic disease
- Symptomatic, untreated, or actively progressing central nervous system metastases requiring glucocorticoids or mannitol
- Significant cardiovascular disease within the past 6 months
- Pregnancy or breastfeeding
- Malignant tumors within the past 5 years except cured skin basal cell carcinoma and cervical carcinoma in situ
- History of autoimmune disease
- Positive HIV test
- Active hepatitis B or C infection
- Uncontrolled pleural effusion or ascites
- Thyroid dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai cancer center
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhi-Ming Shao
CONTACT
Z
Zhong-Hua Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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