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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wangy556@mail.sysu.edu.cn
• Phone: 86-20-34070870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery

  This study tests whether disitamab vedotin with radiotherapy can improve outcomes for people with HER2-expressing upper tract urothelial carcinoma after radical surgery who can’t receive cisplatin.

  Recruiting Phase 3 Peking University First Hospital · Beijing · NCT07498907

• Disitamab vedotin plus SOX versus SOX alone as adjuvant treatment for HER2-moderate/high stage III gastric cancer after surgery

  This trial will test whether adding disitamab vedotin to standard SOX chemotherapy helps people with HER2-moderate/high stage III gastric cancer after surgery stay cancer-free longer or live longer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07474324

• Disitamab vedotin plus bevacizumab for HER2-low metastatic breast cancer after T‑DxD failure

  This study will try disitamab vedotin combined with bevacizumab in adults with HER2‑low metastatic breast cancer whose disease progressed after trastuzumab deruxtecan.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07446452

• Disitamab vedotin plus trastuzumab and tislelizumab versus chemotherapy plus trastuzumab (± pembrolizumab) for HER2‑high advanced gastric or gastroesophageal junction adenocarcinoma

  This trial tests whether combining disitamab vedotin with trastuzumab and the immunotherapy tislelizumab works better than standard chemotherapy with trastuzumab (with or without pembrolizumab) as first‑line treatment for people with HER2‑high advanced gastric or gastroesophageal junction cancer.

  Recruiting Phase 3 RemeGen Co., Ltd. · Beijing, BJ-Beijing · NCT07315750

• Disitamab vedotin plus carboplatin and bevacizumab as first-line and maintenance treatment for HER2-expressing, HRD-negative high-risk ovarian cancer

  This study tests whether adding disitamab vedotin to carboplatin and bevacizumab helps people with HER2-expressing, HRD-negative high-risk ovarian cancer as first-line and maintenance treatment.

  Recruiting Phase 2 Jiangsu Cancer Institute & Hospital · Nanjing, Jiangsu and 1 other locations · NCT07311577

• Disitamab Vedotin plus BCG vs BCG alone in HER2-expressing high-risk NMIBC

  This study tests whether adding disitamab vedotin to BCG helps people with early, high-risk bladder cancer that hasn’t spread outside the bladder.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07207824

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.