Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

NCT ID: NCT05904964

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2030-03-01

Brief Summary

Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%. However, this type of patients lack ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and the median overall survival time is only 30 months. Therefore, finding more efficient and safe therapeutic drugs for these patients has become a big clinical challenge at present. Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high efficiency and precise tumor killing effect with low toxicity. According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low expression as a posterior line treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with endocrine resistance through a scientifically designed, randomized, phase III clinical study.

Conditions

HR Positive/HER2 Low Expression Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disitamab Vedotin

Disitamab Vedotin, 2mg/kg, every 2 weeks

Group Type: EXPERIMENTAL

Disitamab vedotin

Intervention Type: DRUG

Disitamab Vedotin 2mg/kg was injected every 2 weeks,

Endocrine therapy

Doctors choose endocrine therapy independently

Group Type: ACTIVE_COMPARATOR

Endocrine therapy

Intervention Type: OTHER

Doctors choose endocrine therapy independently

Interventions

Disitamab vedotin

Disitamab Vedotin 2mg/kg was injected every 2 weeks,

Intervention Type: DRUG

Endocrine therapy

Doctors choose endocrine therapy independently

Intervention Type: OTHER

Other Intervention Names

RC48

Eligibility Criteria

Inclusion Criteria

1. Adult female patients (aged 18-70 years, including 18 and 70 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;

2. Pathological examination confirmed that ER and / or PR were positive, and HER-2 was low expression (ER expression: immunohistochemical staining of tumor cells ≥ 10%; PR expression: immunohistochemical staining of tumor cells ≥ 10%; HER2-low: immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +);

3. Patients who have received endocrine therapy ;

4. According to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1, there is at least one evaluable target lesion or only osteolytic bone metastasis;

5. Patients with stable brain metastasis or asymptomatic brain metastasis;

6. ECOG physical condition score ≤ 2 points, and the estimated survival time is not less than 3 months;

7. Prior treatment-related toxicity must be relieved to ≤ 1 degree (according to NCI CTCAE 5.0) before enrollment (except for hair loss or other toxicity that is considered as no risk to the safety of patients according to the judgment of the researcher);

8. Adequate bone marrow functional reserve: a. WBC ≥ 3.0 × 10 ^ 9 ／ L, b. Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 ／ L, c. Platelet count (PLT) ≥ 70 × 10^9／L;

9. Liver, kidney and heart function tests were basically normal within one week before enrollment (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), B. alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; d. left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms;

10. Patients understand the research process, voluntarily participate in the research, and sign the informed consent form.

Exclusion Criteria

1. Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;

2. Patients who had performed major surgery within 2 weeks before enrollment.

3. Severe heart disease or discomfort within 12 months, including, but not limited to, the following: unstable angina pectoris, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for silent lacunar cerebral infarction without treatment);

4. Have active autoimmune diseases (such as corticosteroids or immunosuppressive drugs) requiring systemic treatment in the past 2 years, excluding those with adrenal insufficiency requiring corticosteroid replacement therapy;

5. Have a clear history of neurological or mental disorders, including epilepsy or dementia;

6. According to the judgment of the researchers, there are some accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.

7. Those who have been known to have allergic history to Disitamab Vedotin or similar drugs;

8. According to the estimation of the investigator , the patient's compliance with the clinical study is insufficient or the researcher believes that there are other factors that are not suitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Ying Wang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Wang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

The Second Affiliated Hospital， Shantou University Medical College

Shantou, Guangdong, China

Site Status: RECRUITING

Hainan Qionghai People's Hospital

Qionghai, Hainan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Wang

Role: CONTACT

wangy556@mail.sysu.edu.cn

86-20-34070870

Jianli Zhao

Role: CONTACT

zhaojli5@mail.sysu.edu.cn

86-20-34070499

Facility Contacts

Ying Wang

Role: primary

wangy556@mail.sysu.edu.cn

020-34070870

Jianli Zhao

Role: backup

zhaojli5@mail.sysu.edu.cn

020-34070499

Zhiyang Li

Role: primary

Jianbao Wang

Role: primary

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Related Links

https://www.nccn.org/professionals/physician_gls/default.aspx

NCCN Clinical Practical Guidelines in Oncology: Breast Cancer, Version 3.2021.

Other Identifiers

SYSKY-2022-208-01

Identifier Type: -

Identifier Source: org_study_id