NCT05769010

Brief Summary

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
38mo left

Started Mar 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2023Jun 2029

First Submitted

Initial submission to the registry

March 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

March 2, 2023

Last Update Submit

March 27, 2026

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • CNS-ORR by investigator

    CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria

    2 months

Secondary Outcomes (3)

  • ORR by investigator using RECIST Guideline (Version 1.1)

    2 months

  • PFS

    up to 1.5 years

  • Adverse events

    up to 1.5 years

Study Arms (6)

Arm 1

EXPERIMENTAL

HER2-positive: SHR-A1811

Drug: SHR-A1811

Arm 2

EXPERIMENTAL

HER2-positive: SHR-A1811 and pyrotinib

Drug: SHR-A1811Drug: Pyrotinib

Arm 3

EXPERIMENTAL

HER2-positive: SHR-A1811 and bevacizumab

Drug: SHR-A1811Drug: Bevacizumab

Arm 4

EXPERIMENTAL

HER2-low: SHR-A1811

Drug: SHR-A1811

Arm 5

EXPERIMENTAL

HER2-low: SHR-A1811 and bevacizumab

Drug: SHR-A1811Drug: Bevacizumab

Arm 6

EXPERIMENTAL

HER2-low: SHR-A1811 and Adebelizumab

Drug: SHR-A1811Drug: Adebelizumab

Interventions

SHR-A1811DRUG

SHR-A1811: intravenous

Arm 1Arm 2Arm 3Arm 4Arm 5Arm 6
PyrotinibDRUG

Pyrotinib: oral

Arm 2
BevacizumabDRUG

Bevacizumab: intravenous

Arm 3Arm 5
AdebelizumabDRUG

Adebelizumab: intravenous

Arm 6

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females and males ≥18 yrs old;
  • Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
  • At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
  • Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
  • More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
  • Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
  • Life expectancy is not less than 6 months.
  • Adequate function of major organs.

You may not qualify if:

  • Leptomeningeal involvement;
  • CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
  • 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;
  • Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
  • No concurrent antitumor therapy for metastatic cancer other than the study treatment;
  • Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;
  • Participated in other drug clinical trials within 4 weeks before admission;
  • History of clinically significant lung disease；
  • 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.
  • 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.).
  • Any other conditions that researchers believe that patients are unsuitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinibBevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Min Yan, Professor

CONTACT

+86 15713857388ym200678@126.com

HuiMin Lv

CONTACT

+86 15937162120lvhuimin999@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 15, 2023

Study Start

March 31, 2023

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)