Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.

NCT06857747 | Not Yet Recruiting

• 1 other identifier: NCC4532
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the efficacy of Disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By integrating the rapid onset of action of Disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to further improve patients' response rates and enhance their quality of life, building upon the extension of patient survival.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival，PFS

  To evaluate the efficacy of anti-tumor

  21 or 28 days after the last dose

Secondary Outcomes (5)

• Overall survival，OS

  1 year after the last dose

• Objective response rate，ORR

  21 or 28 days after the last dose

• Disease Control Rate，DCR

  21 or 28 days after the last dose

• Duration of Response，DoR

  21 or 28 days after the last dose

• Safety: Hematologic and non-hematologic toxicity (NCI CTCAE v5.0)

  rom the initiation of the first dose to 21 or 28 days after the last dose

Study Arms (2)

HER2-positive advanced breast cancer

EXPERIMENTAL

Patients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle.

Drug: Capecitabine; Drug: Vinorelbine; Drug: Etoposide

HER2 2+/1+ expressed in IHC advanced breast cancer

EXPERIMENTAL

Patients will receive disitamab vedotin combining with metronomic chemotherapy in a 3-week treatment cycle.

Drug: Capecitabine; Drug: Vinorelbine; Drug: Etoposide

Interventions

Capecitabine DRUG

metronomic capecitabine, 500 mg, tid， po

HER2 2+/1+ expressed in IHC advanced breast cancer; HER2-positive advanced breast cancer

Vinorelbine DRUG

metronomic vinorelbine, 40mg/d, TIW1, po

HER2 2+/1+ expressed in IHC advanced breast cancer; HER2-positive advanced breast cancer

Etoposide DRUG

metronomic etoposide, 50mg/d, po

HER2 2+/1+ expressed in IHC advanced breast cancer; HER2-positive advanced breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in the study and sign an informed consent form;
• Male or female, aged ≥18 years;
• Expected survival period ≥12 weeks;
• Patients with histologically confirmed HER2-positive advanced breast cancer;
• Measurable lesions as defined by RECIST v1.1 criteria;
• Ability to provide tumor samples for HER2 testing from the primary or metastatic lesion:
• HER2-positive definition: confirmed by immunohistochemistry (IHC) score of 3+ or 2+/fish+;
• HER2 low expression definition: confirmed by IHC score of 2+/1+;
• Previous treatment requirements:
• HER2 3+: previously received at least 1 line of treatment;
• HER2 low HR+: progression after prior endocrine therapy and \<3 lines of chemotherapy;
• HER2 low HR-: \<3 lines of chemotherapy in the past;
• ECOG performance status score 0-1;
• Adequate cardiac, bone marrow, liver, and renal function (according to the normal values of the research center):
• Hematologic criteria:

You may not qualify if:

• Patients with central nervous system metastases and/or carcinomatous meningitis. Patients who have undergone treatment for brain metastases may be considered for participation in this study provided that their condition has remained stable for at least 3 months, there is no evidence of disease progression on imaging performed within 4 weeks prior to the initiation of study treatment, all neurological symptoms have returned to baseline levels, there is no evidence of new or enlarging brain metastases, and there has been a discontinuation of radiation, surgery, or corticosteroid therapy for at least 28 days prior to the initiation of study treatment. This exception does not apply to carcinomatous meningitis, which should be excluded regardless of clinical stability.
• Toxicities from prior anti-tumor therapy have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 (except for grade 2 alopecia).
• Major surgery within 4 weeks prior to the start of study treatment and incomplete recovery.
• Clinically significant pleural effusion or ascites requiring symptomatic treatment.
• Receipt of attenuated live vaccines within 30 days prior to or anticipated during the study period.
• Occurrence of a severe thromboembolic event or cerebrovascular accident within 1 year prior to study treatment initiation, such as deep vein thrombosis (excluding asymptomatic and non-interventional muscle venous thrombosis), pulmonary embolism, stroke, intracranial hemorrhage, myocardial infarction, except for asymptomatic and clinically non-interventional lacunar infarction.
• Heart failure categorized as New York Heart Association (NYHA) class 3 or higher.
• Presence of systemic diseases judged by the investigator to be unstable, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive lung disease, etc.
• Active autoimmune disease requiring systemic therapy within 2 years prior to study treatment initiation (such as use of immunomodulatory drugs, corticosteroids, or immunosuppressants), with permitted alternative therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency).
• Severe infection within 4 weeks prior to the first dose of study treatment (e.g., requiring intravenous administration of antibiotics, antifungals, or antiviral drugs), or occurrence of unexplained fever \>38.5°C during the screening period or within 3 weeks prior to the first dose of study treatment.
• Active autoimmune disease or immunodeficiency, or a history thereof, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc. Exceptions include patients with a history of autoimmune thyroiditis who receive thyroid hormone replacement therapy or patients with type 1 diabetes whose blood glucose is controlled with insulin therapy.
• Active or poorly controlled severe infections, including:
• Human Immunodeficiency Virus (HIV) (positive for HIV1/2 antibodies);
• Active hepatitis B (positive for HBsAg or abnormal liver function with HBV DNA \>2000IU/ml);
• Active hepatitis C (positive for HCV antibodies or HCV RNA ≥103 copies/ml with abnormal liver function);

Sponsors & Collaborators

• QIAO LI: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Vinorelbine; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Qiao Li, Dr.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Qiao Li, Dr.

CONTACT

+086-87788820; liqiaopumc@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinial professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2024-03