Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205200
• Other study ID #: FUSCC
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: Zhi-Ming Shao
• Phone: 86-021-64175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: August 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer

Intervention

Drug:
• SHR-1316
PD-L1 antibody
• SHR6390
CDK4/6 inhibitor
• Nab paclitaxel
Albumin bound paclitaxel
• SERD
Fulvestrant
• AI
aromatase inhibitor

Locations

Country	Name	City	State
China	Fudan University Shanghai cancer center	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

Fudan University

Affiliated Hospital of Nantong University, Chongqing University Cancer Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, Fujian Medical University Union Hospital, Liaoning Tumor Hospital & Institute, Ningbo Medical Center Lihuili Hospital, Northern Jiangsu People's Hospital, Peking University Cancer Hospital & Institute, Shanghai 6th People's Hospital, Shanghai First Maternity and Infant Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	time to progressive disease (according to RECIST1.1)	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)
Secondary	ORR	The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)	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)
Secondary	CBR	the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the	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)
Secondary	OS	time to death due to any cause	Randomization to death from any cause, through the end of study (approximately 5 years)