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Trial Title:
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
NCT ID:
NCT05814354
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Gemcitabine
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel model, randomized at a 1:1 ratio
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to
label, as one option for Physician's Choice.
Arm group label:
SHR-A1811
Intervention type:
Drug
Intervention name:
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Description:
Administered according to label, as one option for Physician's Choice (determined before
randomization).
Arm group label:
Physician's Choice
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Binghe Xu, Doctor
Phone:
+86-13501028690
Email:
xubinghe@medmail.com.cn
Start date:
June 30, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814354
