Clinical trial · Interventional
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruiting was not possible
Summary
Brief summary (as posted)
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalmab&Tremelimumab&Fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalmab&Tremelimumab&Fulvestrant
- description
- Durvalmab\&Tremelimumab\&Fulvestrant
- interventionNames
- Drug: Durvalmab&Tremelimumab&Fulvestrant
Primary outcomes (1)
- measure
- Response rate based on RECIST1.1
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged \>= 20 years at informed consent. 2. Patients who have provided written informed consent themselves. 3. Patients who have metastatic and/or advanced lesion 4. Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells). 5. Patients with cancer confirmed to be HER2-negative. 6. Patients with confirmed menopause 7. Patients who have plans of 2nd hormone therapy. 8. Patients with a measurable lesion based on RECIST 1.1 9. Patients with ECOG PS of 0 to 1. 10. Patients without any severe disorder in the major organs. Exclusion Criteria: \- Exclusion Criteria: 1. Active or prior documented autoimmune disease within the past 2 years. 2. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab 3. Patients with central nervous system metastasis 4. Patients with life-threatening disease. 5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug. 6. Patients who have received live vaccination within 30 days before start of the investigational products. 7. Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia. 8. Patients considered ineligible for participation in this study by their attending physicians.
References
Publications (0)
Data not yet available