Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Disitamab vedotin

Immunoconjugates

Immunologic Factors

Disitamab Vedotin（RC48-ADC）with Toripalimab （JS001）arm

2.0 mg/kg intravenous (lV) infusion every 2 weeks

Disitamab Vedotin

3.0 mg/kg intravenous (lV) infusion every 2 weeks

Toripalimab

Jianmin Fang, Ph.D

This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.

Eligible patients will be those patients who have had disease progression on at least 1 previous line of endocrine therapies given for the treatment of metastatic disease or relapsed within 12 months of the end of adjuvant endocrine therapy or during adjuvant endocrine therapy, patients treated with CDK4/6 inhibitors require ≥50%. All patients must have historically confirmed HR positive, HER2-low (defined as IHC2+/ISH- and IHC 1+) expression, as determined by central laboratory testing results, advanced breast cancer. IHC 1+ account for no more than 60% The study aims to evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC. This study aims to see if RC48-ADC with JS001 allows patients to live longer without the cancer getting worse, compared to patients receiving RC48-ADC. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer

An Randomized, Open-label, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive, HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer

Defined as time from date of randomization until the date of objective radiological disease progression by investigator assessment according to RECIST v1.1 or death.

Defined as the time from randomization to death due to any cause

Defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by Investigator assessment according to RECIST v1.1.

Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.

Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1

According to NCI-CTCAE Version 5.0 per each treatment arm

To be summarized using descriptive statistics

Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden

Spots Global Cancer Trial Database for hr+breast cancer