Immune therapy for advanced breast cancer
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer
This study is testing different immune therapies for people with advanced breast cancer to see if they can help those who have or haven’t been treated with certain medications before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05205200 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study focuses on patients with HR+/HER2- advanced breast cancer, specifically targeting the SNF2 subtype. It is a prospective, open-label trial that aims to evaluate the effectiveness of various immune therapies in patients who have or have not previously been treated with CDK4/6 inhibitors. The study includes five treatment arms and is designed to gather data to support future larger randomized controlled trials. Patients will be enrolled based on specific histological criteria confirmed by a specialized pathology department.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 with histologically confirmed HR+/HER2- invasive breast cancer of the SNF2 subtype.
Not a fit: Patients with other subtypes of breast cancer or those who do not meet the specific histological criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with a specific subtype of advanced breast cancer.
How similar studies have performed: Other studies have shown promise in using immune therapies for breast cancer, but this specific approach targeting the SNF2 subtype is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females ≥18 years and ≤ 75 years old; * Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative); * Subtype of similarity network fusion-2 (SNF-2) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital * Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL; * Patients had received no previous chemotherapy or targeted therapy for metastatic disease * Has adequate liver function and kidney function: serum creatinine * ECOG score ≤ 2 and life expectancy ≥ 3 months; * Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: * Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms); * Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ). * History of autoimmune disease * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Uncontrolled pleural effusion and ascites * Thyroid dysfunction.
Where this trial is running
Shanghai
- Fudan University Shanghai cancer center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Zhi-Ming Shao — Fudan University
- Study coordinator: Zhi-Ming Shao
- Email: zhimingshao@yahoo.com
- Phone: 86-021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.