NCT05814354

Brief Summary

The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
530

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
2mo left

Started Jun 2023

Shorter than P25 for phase_3 breast-cancer

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 Progress97%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

April 3, 2023

Last Update Submit

July 19, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)

    within approximately 2 years

Secondary Outcomes (4)

  • Overall Survival (OS)

    within approximately 3 years

  • Objective Response Rate (ORR)

    within approximately 2 years

  • Duration of Response (DoR)

    within approximately 2 years

  • Clinical Benefit Rate (CBR)

    within approximately 2 years

Study Arms (2)

SHR-A1811

EXPERIMENTAL
Drug: SHR-A1811

Physician's Choice

ACTIVE COMPARATOR

Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Interventions

SHR-A1811DRUG

SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.

SHR-A1811
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxelDRUG

Administered according to label, as one option for Physician's Choice (determined before randomization).

Physician's Choice

Eligibility Criteria

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

You may qualify if:

  • Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
  • HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
  • Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
  • Has documented radiologic progression (during or after most recent treatment).
  • Has at least 1 protocol-defined measurable lesion.
  • Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
  • Fertile women (WOCBP) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment.

You may not qualify if:

  • Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
  • A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
  • History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
  • Has moderate or severe cardiovascular disease.
  • Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects.
  • Any other malignancies within 5 years except for those with negligible risk of metastasis or death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shouwei Zhao

CONTACT

18036617887shouwei.zhao@hengrui.com

Xia Zhang

CONTACT

18964112341xia.zhang@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel model, randomized at a 1:1 ratio
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

June 30, 2023

Primary Completion

January 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

CN(1)