SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: SHR-A1811; Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xia Zhang; Phone Number: 18964112341; Email: xia.zhang@hengrui.com
• Study Contact Backup: Name: Shouwei Zhao; Phone Number: 18036617887; Email: shouwei.zhao@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Binghe Xu, Doctor; Phone Number: +86-13501028690; Email: xubinghe@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
2. 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.
3. Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
4. Has documented radiologic progression (during or after most recent treatment).
5. Has at least 1 protocol-defined measurable lesion.
6. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
7. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A1811	Drug: SHR-A1811; SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
Active Comparator: Physician's Choice; Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel	Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel; Administered according to label, as one option for Physician's Choice (determined before randomization).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)	within approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from the date of randomization to the date of death for any cause. If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.	within approximately 3 years
Objective Response Rate (ORR)	Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.	within approximately 2 years
Duration of Response (DoR)	DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.	within approximately 2 years
Clinical Benefit Rate (CBR)	CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.	within approximately 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Capecitabine; Gemcitabine
• Other Study ID Numbers: SHR-A1811-III-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No