Clinical trial · Interventional
Reverse HER2-negative Immune Resistant Breast Cancer
NCT06731140CI-TRIAL-00097251ResilirerecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 antibody and chemotherapy | Drug | — | UNRESOLVED |
| Retinoic Acid | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- retinoic acid with anti-PD-1 immunotherapy
- description
- retinoic acid with anti-PD-1 immunotherapy
- interventionNames
- Drug: Retinoic Acid
- Drug: anti-PD-1 antibody and chemotherapy
Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
- measure
- Clinical Benefit Rate (CBR)
- timeFrame
- Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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
References
Publications (0)
Data not yet available
No reference posted for this study.