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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814354
• Other study ID #: SHR-A1811-III-306
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Shouwei Zhao
• Phone: 18036617887
• Email: shouwei.zhao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: June 30, 2026
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SHR-A1811
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
• Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization).

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)		within approximately 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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