SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial (NCT05814354) | Clinical Trial Compass
Active — Not RecruitingPhase 3
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
China551 participantsStarted 2023-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
. 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.