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

February 6, 2024 updated by: Zhimin Shao, Fudan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

338

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhong-Hua Wang

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1A
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy.
Drug: SHR-1316
PD-L1 antibody
Drug: SHR6390
CDK4/6 inhibitor
Drug: SERD
Fulvestrant
Drug: AI
aromatase inhibitor
Active Comparator: Cohort 1B
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy.
Drug: SHR6390
CDK4/6 inhibitor
Drug: SERD
Fulvestrant
Drug: AI
aromatase inhibitor
Experimental: Cohort 2A
In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel.
Drug: SHR-1316
PD-L1 antibody
Drug: Nab paclitaxel
Albumin bound paclitaxel
Active Comparator: Cohort 2B
In this cohort, a patient would single nab-paclitaxel.
Drug: Nab paclitaxel
Albumin bound paclitaxel
Other: Cohort 2C
In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant.
Drug: SHR-1316
PD-L1 antibody
Drug: SERD
Fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 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)
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)
CBR
Time Frame: 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
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)
OS
Time Frame: Randomization to death from any cause, through the end of study (approximately 5 years)
time to death due to any cause
Randomization to death from any cause, through the end of study (approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

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

Investigators

  • Principal Investigator: Zhi-Ming Shao, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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