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

NCT05205200 | Recruiting Phase 2 DMC

• 1 other identifier: FUSCC
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Metastatic Cancer

Keywords

first-line therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• OS

  Randomization to death from any cause, through the end of study (approximately 5 years)

Study Arms (5)

Cohort 1A

EXPERIMENTAL

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy.

Drug: SHR-1316; Drug: SHR6390; Drug: SERD; Drug: AI

Cohort 1B

ACTIVE COMPARATOR

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy.

Drug: SHR6390; Drug: SERD; Drug: AI

Cohort 2A

EXPERIMENTAL

In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel.

Drug: SHR-1316; Drug: Nab paclitaxel

Cohort 2B

ACTIVE COMPARATOR

In this cohort, a patient would single nab-paclitaxel.

Drug: Nab paclitaxel

Cohort 2C

OTHER

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant.

Drug: SHR-1316; Drug: SERD

Interventions

SHR-1316 DRUG

PD-L1 antibody

Cohort 1A; Cohort 2A; Cohort 2C

SHR6390 DRUG

CDK4/6 inhibitor

Cohort 1A; Cohort 1B

Nab paclitaxel DRUG

Albumin bound paclitaxel

Cohort 2A; Cohort 2B

SERD DRUG

Fulvestrant

Cohort 1A; Cohort 1B; Cohort 2C

AI DRUG

aromatase inhibitor

Cohort 1A; Cohort 1B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai cancer center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Taxes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Zhi-Ming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Ming Shao

CONTACT

86-021-64175590; zhimingshao@yahoo.com

Zhong-Hua Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: June 6, 2022
• Primary Completion: February 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

CN (1)