Clinical trial NCT05814354: SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
Official title: A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 530
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model, randomized at a 1:1 ratio
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
timeFrame: within approximately 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: within approximately 3 years
measure: Objective Response Rate (ORR)
timeFrame: within approximately 2 years
measure: Duration of Response (DoR)
timeFrame: within approximately 2 years
measure: Clinical Benefit Rate (CBR)
timeFrame: within approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: