Breast Cancer
Conditions
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.
Interventions
DRUGSHR-A1811
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
DRUGCapecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization).
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel model, randomized at a 1:1 ratio
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC) | within approximately 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed