SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
- Conditions
- Breast Cancer
- Interventions
- Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- Registration Number
- NCT05814354
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 530
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-A1811 SHR-A1811 - Physician's Choice Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC) within approximately 2 years
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) within approximately 3 years 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.
Objective Response Rate (ORR) within approximately 2 years Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.
Duration of Response (DoR) within approximately 2 years DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Clinical Benefit Rate (CBR) within approximately 2 years CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Trial Locations
- Locations (1)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China