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Study of SHR-A1811 in HER2-positive Advanced Breast Cancer With Brain Metastases

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05769010
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
36
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2025
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

SHR-A1811

Drug: SHR-A1811
SHR-A1811: intravenous
Experimental: Arm 2

SHR-A1811 and pyrotinib

Drug: SHR-A1811
SHR-A1811: intravenous

Drug: Pyrotinib
Pyrotinib: oral
Experimental: Arm 3

SHR-A1811 and bevacizumab

Drug: SHR-A1811
SHR-A1811: intravenous

Drug: Bevacizumab
Bevacizumab: intravenous

Outcome Measures

Primary Outcome Measures

  1. CNS-ORR by investigator [2 months]

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

Secondary Outcome Measures

  1. ORR by investigator using RECIST Guideline (Version 1.1) [2 months]

    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1

  2. PFS [up to 1.5 years]

    PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first

  3. Adverse events [up to 1.5 years]

    Proportion of participants experienced adverse events during the study period

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Females ≥18 yrs old;

  2. Pathologically confirmed HER2-positive advanced breast cancer;

  3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;

  4. No indication for immediate local treatment or refuse to local treatment;

  5. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.

  6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;

  7. Life expectancy is not less than 6 months.

  8. Adequate function of major organs.

Exclusion Criteria:

  1. Leptomeningeal involvement;

  2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;

  3. 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;

  4. 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;

  5. No other therapy for metastatic disease;

  6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;

  7. Participated in other drug clinical trials within 4 weeks before admission;

  8. History of clinically significant lung disease；

  9. 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.

  10. 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.).

  11. Any other conditions that researchers believe that patients are unsuitable for this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital Zhengzhou Henan China

Sponsors and Collaborators

  • Henan Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min Yan, MD, Chief Physician, Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05769010
Other Study ID Numbers:
  • HNCH-MBC12
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Brain Neoplasms
Bevacizumab

Study Results

No Results Posted as of Mar 15, 2023