Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
Phase 2
Recruiting
- Conditions
- Breast CancerMetastatic Cancer
- Interventions
- Registration Number
- NCT05205200
- Lead Sponsor
- Fudan University
- Brief Summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Detailed Description
Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 338
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2B Nab paclitaxel In this cohort, a patient would single nab-paclitaxel. Cohort 1A SHR6390 In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. Cohort 1B SHR6390 In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy. Cohort 2A SHR-1316 In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel. Cohort 2C SERD In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant. Cohort 1A SHR-1316 In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. Cohort 1B SERD In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy. Cohort 2C SHR-1316 In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant. Cohort 1A SERD In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. Cohort 1A AI In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. Cohort 1B AI In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy. Cohort 2A Nab paclitaxel In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel.
- Primary Outcome Measures
Name Time Method PFS Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) time to progressive disease (according to RECIST1.1)
- Secondary Outcome Measures
Name Time Method OS Randomization to death from any cause, through the end of study (approximately 5 years) time to death due to any cause
ORR Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
CBR Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the
Trial Locations
- Locations (1)
Fudan University Shanghai cancer center
🇨🇳Shanghai, China