Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
NCT ID: NCT05205200
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
338 participants
INTERVENTIONAL
2022-06-06
2026-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
NCT05132790
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC
NCT04001634
Reverse HER2-negative Immune Resistant Breast Cancer
NCT06731140
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
NCT06121570
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
NCT05759572
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1A
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy.
SHR-1316
PD-L1 antibody
SHR6390
CDK4/6 inhibitor
SERD
Fulvestrant
AI
aromatase inhibitor
Cohort 1B
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy.
SHR6390
CDK4/6 inhibitor
SERD
Fulvestrant
AI
aromatase inhibitor
Cohort 2A
In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel.
SHR-1316
PD-L1 antibody
Nab paclitaxel
Albumin bound paclitaxel
Cohort 2B
In this cohort, a patient would single nab-paclitaxel.
Nab paclitaxel
Albumin bound paclitaxel
Cohort 2C
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant.
SHR-1316
PD-L1 antibody
SERD
Fulvestrant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-1316
PD-L1 antibody
SHR6390
CDK4/6 inhibitor
Nab paclitaxel
Albumin bound paclitaxel
SERD
Fulvestrant
AI
aromatase inhibitor
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Cancer Hospital & Institute
OTHER
First Hospital of China Medical University
OTHER
Sun Yat-sen University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Chongqing University Cancer Hospital
OTHER
Northern Jiangsu People's Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Shanghai First Maternity and Infant Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhimin Shao
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhi-Ming Shao
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Shanghai cancer center
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Zhong-Hua Wang
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FUSCC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.