NCT05814354Active, not recruitingPhase 3
A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country551 target enrollmentStarted: June 30, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 551
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- •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.
Arms & Interventions
Physician's Choice
Active Comparator
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Intervention: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel (Drug)
SHR-A1811
Experimental
Intervention: SHR-A1811 (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
Time Frame: within approximately 2 years
Secondary Outcomes
- Overall Survival (OS)(within approximately 3 years)
- Objective Response Rate (ORR)(within approximately 2 years)
- Duration of Response (DoR)(within approximately 2 years)
- Clinical Benefit Rate (CBR)(within approximately 2 years)
Investigators
Study Sites (1)
Loading locations...
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