Reverse Luminal Immune Resistant Breast Cancer

Phase 2

Recruiting

• Conditions: Luminal Breast Cancer
• Interventions: Drug: Retinoic Acid; Drug: anti-PD-1 antibody and chemotherapy

• Registration Number: NCT06731140
• Lead Sponsor: Fudan University

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 luminal breast cancer patients who progressed during previous immune checkpoint inhibitors.

Detailed Description

This is a Phase II, open-label study evaluating the efficacy and safety of combined treatment (retinoic acid) with immune checkpoint inhibitors in metastatic luminal breast cancer patients who progressed during or following previous immune checkpoint inhibitors. Current clinical studies on immunotherapy for luminal breast cancer are limited, with inconsisten...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• ECOG Performance Status of 0, 1, or 2
• Metastatic or locally advanced, histologically documented luminal breast cancer (presence of ER and/or PR expression, and absent or low HER2 expression)
• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
retinoic acid with anti-PD-1 immunotherapy	Retinoic Acid	retinoic acid with anti-PD-1 immunotherapy
retinoic acid with anti-PD-1 immunotherapy	anti-PD-1 antibody and chemotherapy	retinoic acid with anti-PD-1 immunotherapy

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
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	Retinoic acid related genes and macrophage function will be measured in pretreatment tissues to predict therapy response.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China