Reverse HER2-negative Immune Resistant Breast Cancer
Resilire
1 other identifier
interventional
10
1 country
1
Brief Summary
This is a Phase II, open-label study evaluating the efficacy and safety of combined treatment (retinoic acid) with immune checkpoint inhibitor in HER2-negative breast cancer patients who progressed during previous immune checkpoint inhibitors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 12, 2024
CompletedStudy Start
First participant enrolled
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
November 17, 2025
May 1, 2025
1.6 years
December 9, 2024
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR)
Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) is defined as the proportion of subjects who achieve a complete response (CR), partial response (PR), or have durable stable disease (SD) after treatment. It is intended to measure a clinically meaningful and broader disease control effect. CBR includes subjects who have achieved CR and PR, as well as those who have maintained SD for a specified duration (≥24 weeks). The evaluation is based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Subjects must have measurable tumor lesions at baseline. The efficacy assessment is categorized into CR, PR, SD, and Progressive Disease (PD) according to RECIST 1.1 criteria.
Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Immune changes in peripheral blood
Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary Outcomes (4)
Disease Control Rate (DCR)
Baseline through end of study, assessed up to 6 months
Progression Free Survival (PFS)
Randomization to death from any cause, through the end of study, assessed up to 6 months
Safety and treatment-related AEs
Randomization to death from any cause, through the end of study, assessed up to 12 months
Biomarker analysis
Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Study Arms (1)
retinoic acid with anti-PD-1 immunotherapy
EXPERIMENTALretinoic acid with anti-PD-1 immunotherapy
Interventions
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Eligibility Criteria
You may qualify if:
- ECOG Performance Status of 0, 1, or 2
- Metastatic or locally advanced, histologically confirmed luminal breast cancer (defined as: ER positive when immunohistochemistry shows \>1% positive tumor cells, PR positive when \>1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH) or triple negative breast cancer (defined as: ER negative when immunohistochemistry shows \<1% positive tumor cells, PR negative when \<1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH).
- Radiologic/objective evidence of recurrence or disease progression after immunotherapy (combined with targeted therapy or chemo ) for metastatic breast cancer (MBC)
- Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
You may not qualify if:
- Symptomatic, untreated, or actively progressing CNS metastases
- Active or history of autoimmune disease or immune deficiency
- Significant cardiovascular disease
- History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- History of allergies to the drug components of this trial
- History of eosinophilosis or mastocytosis
- Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 12, 2024
Study Start
February 12, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
November 17, 2025
Record last verified: 2025-05