Actively Recruiting
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2023-07-20
530
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 18 and 75 years
- Low HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
- Hormone receptor-positive breast cancer with prior endocrine therapy and disease progression
- Received 0 to 1 prior chemotherapy lines in the metastatic setting
- Documented radiologic progression during or after most recent treatment
- At least one measurable lesion as defined by the protocol
- Adequate heart, bone marrow, kidney, liver, and blood clotting function
- Fertile women must agree to use effective contraception and not breastfeed during and for 7 months after treatment, with a negative pregnancy test before starting treatment
You will not qualify if you...
- Known active central nervous system metastases; stable previously treated brain metastases allowed
- Known HIV infection or active autoimmune disease
- History of interstitial lung disease or pneumonia requiring steroid treatment
- Moderate or severe cardiovascular disease
- Active hepatitis B or hepatitis C infection
- Other cancers within 5 years except those with very low risk of spread or death
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
S
Shouwei Zhao
CONTACT
X
Xia Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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