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PD-L1 Inhibitor + RT ± Ursodeoxycholic Acid in Recurrent/Metastatic HER2-Neg Breast Cancer Phase 2 70 Immunotherapy Overall Survival

Not yet recruiting
Clinical Trial NCT06842472 is designed to study Treatment for Breast Cancer. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on February 1, 2025 until the study accrues 70 participants. Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, this study is expected to complete by December 1, 2029. The latest data from ClinicalTrials.gov was last updated on February 24, 2025.
Brief Summary
Experimental Group Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks. Radiotherapy (Stereotactic Body Radiation Therapy, SBRT) with a dose of 24 Gy/3 fractions within 3 weeks after the first immunotherapy dose.

Ursodeoxycholic Acid (UDCA) 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after radiotherapy completion.

Control Group Adebrelimab 1200 mg on Day 1, every 3 w...

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Official Title

A Prospective Phase II Randomized Clinical Trial of PD-L1 Monoclonal Antibody in Combination with Radiation Therapy, with or Without Ursodeoxycholic Acid, in Patients with Recurrent or Metastatic HER2-Negative Breast Cancer

Conditions
Breast Cancer
Other Study IDs
  • NCC5137；Approve No.25/004-0004
NCT ID Number
NCT06842472
Start Date (Actual)
2025-02
Last Update Posted
2025-02-24
Completion Date (Estimated)
2029-12
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental Group
Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks. Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose. UDCA 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after radiotherapy completion.
Ursodeoxycholic Acid (URSO)
UDCA 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after completion.
Radiotherapy
Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose.
Adebrelimab (PD-L1 inhibitor)
Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks.
Active ComparatorControl Group
Adebrelimab 1200 mg on Day 1, every 3 weeks. Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose.
Radiotherapy
Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose.
Adebrelimab (PD-L1 inhibitor)
Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective Response Rate (ORR) of lesions outside the radiotherapy field, assessed by RECIST 1.1 criteria.
From date of randomization to 4 weeks after completion of radiotherapy
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Disease Control Rate (DCR) of lesions outside the radiation field, assessed by RECIST 1.1 criteria
From date of randomization to 4 weeks after completion of radiotherapy
Safety: Incidence of Grade ≥3 toxicities, assessed by CTCAE 5.0 criteria
From first dose of study drug to 30 days post-treatment completion
Objective Response Rate (ORR) of lesions within the radiation field, assessed by RECIST 1.1 criteria
From date of randomization to 4 weeks after completion of radiotherapy
Overall response assessment of lesions both within and outside the radiation field, assessed by mRECIST criteria
From date of randomization to 4 weeks after completion of radiotherapy
Progression-Free Survival (PFS): Time from randomization to the first documented progression or death, whichever occurs first
From randomization to the first documented progression or death, whichever occurs first, assessed every 6 weeks up to 48 weeks post-randomization.
Overall Survival (OS): time from randomization to death from any cause
From randomization to death from any cause, assessed continuously until all patients have died (up to 5 years post-randomization).
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  1. Age ≥ 18 years；
  2. Patients with recurrent/metastatic HER2-negative breast cancer；
  3. Patients who have previously received standard treatment regimens for recurrent/metastatic breast cancer；
  4. At least one lesion suitable for radiation therapy；
  5. At least one measurable metastatic lesion outside of the radiation field, and can be monitored using the "Response Evaluation Criteria in Solid Tumors" (RECIST) version 1.1；
  6. ECOG performance status of 0-2；
  7. Signed informed consent；
  8. Patients who have previously received radiation therapy may be included as long as it does not interfere with irradiation of the target lesion；

  1. Biliary obstruction, acute or chronic cholecystitis or cholangitis, or long-term biliary colic (contraindication for UDCA)；
  2. Malabsorption syndrome or diseases that significantly affect gastrointestinal function; patients who have undergone total gastrectomy or resection of the proximal small intestine that may affect oral drug absorption；
  3. Exclusion of patients with symptomatic brain metastases or leptomeningeal metastasis; patients with brain metastases who have been treated and stabilized (with no progression within 4 weeks) may be included, but brain metastases cannot be used as target lesions；
  4. Known invasive malignancies within the past 5 years that are still progressing or require active treatment (excluding patients with basal cell carcinoma, squamous cell carcinoma of the skin, or breast ductal carcinoma in situ or cervical carcinoma in situ who have received curative treatment)；
  5. Previous immune therapy resulting in grade 3 or higher adverse events； Diagnosed with immunodeficiency or receiving long-term systemic corticosteroid treatment (prednisone equivalent dose >10 mg daily) or any form of immunosuppressive therapy within 7 days before the first dose of study treatment；
  6. Active autoimmune diseases requiring systemic treatment (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years；
  7. Active infections requiring systemic treatment；
  8. Known history of active tuberculosis；
  9. Other significant cardiovascular diseases, including recent myocardial infarction, acute coronary syndrome, or a history of coronary artery interventions (angioplasty, stent placement, or bypass surgery) within the last 6 months; NYHA Class II-IV congestive heart failure (CHF) or a history of NYHA Class III or IV CHF；
  10. Known history of human immunodeficiency virus (HIV) infection
Cancer Institute and Hospital, Chinese Academy of Medical Sciences logoCancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Responsible Party
Shulian Wang, Principal Investigator, Prof, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Central Contact
Contact: Min Deng, Doctor, 13661135602, [email protected]
No location data.