Clinical trial · Interventional
SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases
A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
NCT06361979CI-TRIAL-00075981unknownPhase 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 study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases
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 |
|---|---|---|---|
| Breasr Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM1
- interventionNames
- Drug: SHR-A1811
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- CNS-ORR
- timeFrame
- Up to 2 years
- description
- CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Secondary outcomes (3)
- measure
- PFS
- timeFrame
- up to 2 years
- description
- PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years old; 2. Pathologically confirmed HER2-positive breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. 5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed; 6. Adequate function of major organs- Exclusion Criteria: 1. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 2. Previous treatment with bevacizumab; 3. Participated in other drug clinical trials within 4 weeks before admission; 4. History of clinically significant lung disease； 5. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 6. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.). 7. Any other conditions that researchers believe that patients are unsuitable for this study. \-
References
Publications (0)
Data not yet available
No reference posted for this study.