Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.