Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients

NCT07560475 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-BC-II-145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer

Conditions

HER2positive; Advanced Breast Cancer; HER2 + Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Defined as the proportion of patients who achieve confirmed complete response (CR) or partial response (PR) to the study treatment, assessed per RECIST 1.1 criteria.

  From enrollment until disease progression or up to 2 years

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  From enrollment until disease progression or up to 2 years

Other Outcomes (2)

• Overall Survival (OS)

  From enrollment until all-cause death.

• Safety and Tolerability

  From first dose of study drug up to 30 days after last dose

Study Arms (2)

Arm 1: Weekly administration group

EXPERIMENTAL

Drug: SHR-A1811

Arm 2: Every-two-weeks (Q2W) administration group

EXPERIMENTAL

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

SHR-A1811 administered weekly

Arm 1: Weekly administration group

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 18 years old.
• Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in \>10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
• Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
• Expected survival time ≥ 4 months.
• Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
• Adequate major organ function without blood transfusion.
• Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.

You may not qualify if:

• Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
• Known leptomeningeal metastasis or active brain metastasis.
• A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
• Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
• Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
• Presence of hereditary bleeding tendency or coagulation disorders.
• Uncontrolled hypertension with systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg despite standard antihypertensive therapy.
• A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).
• A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.
• Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
• Known allergy to any component of the study drugs.
• Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.
• Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.
• Any other conditions considered inappropriate for study enrollment by the investigator.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute and Hospital

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)