Disitamab Vedotin for treating hormone receptor positive, HER2-low metastatic breast cancer

Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression

This study is testing a new drug called Disitamab Vedotin to see if it can help people with hormone receptor positive, HER2-low metastatic breast cancer who haven't responded to standard treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: Disitamab, chemotherapy, immunotherapy
• Locations: 3 sites (Guangzhou, Guangdong and 2 other locations)
• Trial ID: NCT05904964 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Disitamab Vedotin, a new antibody-drug conjugate, in patients with hormone receptor positive and HER2-low metastatic breast cancer who have shown resistance to standard endocrine therapy. The trial aims to provide a more effective treatment option for this patient population, which currently has limited therapeutic choices after first-line treatment failure. Participants will receive Disitamab Vedotin alongside endocrine therapy, with the goal of achieving better tumor response rates and overall survival. The study will evaluate the treatment's effectiveness based on established criteria for solid tumors.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18-70 with hormone receptor positive, HER2-low metastatic breast cancer who have previously received endocrine therapy.

Not a fit: Patients with HER2-positive breast cancer or those who have not received prior endocrine therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with a challenging subtype of metastatic breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar antibody-drug conjugates in treating metastatic breast cancer, indicating potential for success in this approach.

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.

Where this trial is running

Guangzhou, Guangdong and 2 other locations

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The Second Affiliated Hospital， Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
• Hainan Qionghai People's Hospital — Qionghai, Hainan, China (Recruiting)

Study contacts

• Principal investigator: Ying Wang — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Ying Wang

Conditions HR Positive/HER2 Low Expression Metastatic Breast Cancer; HR positive; HRE2 low expression; metastatic breast cancer; ADC