Trastuzumab Plus Taxane Neoadjuvant Therapy for HER2-Positive Breast Ductal Carcinoma In Situ (DCIS) : A Phase II Study

NCT06843681 | Enrolling By Invitation Phase 2

• 1 other identifier: SYSKY-2024-746-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive carcinoma).

Conditions

Breast Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• Breast-conserving surgery rate after 4-6 cycles of treatment

  The breast-conserving surgery rate was calculated as a percentage of the total number of patients who successfully completed breast-conserving surgery after neoadjuvant therapy. For this study, all patients were required to confirm after treatment that the tumor was resectable and had no significant metastasis by imaging evaluation, such as breast ultrasound or MRI.

  From the start of neoadjuvant therapy to the completion of surgery (approximately 3-4 months after enrollment)

Secondary Outcomes (8)

• pathological Complete Response (pCR)

  Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.

• Objective Response Rate (ORR)

  Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.

• Event-free survival (EFS) of 3 years

  At 36 months from the date of enrollment.

• Event-free survival (EFS) of 5 years

  At 60 months from the date of enrollment.

• Overall survival

  From enrollment to 60 months ± 3 months or until the date of death from any cause, whichever occurs first.

Study Arms (1)

treatment

EXPERIMENTAL

The study includes a single treatment arm where all participants will receive a combination of trastuzumab and taxane as part of the neoadjuvant therapy. This treatment arm is designed to assess the efficacy and safety of the regimen in patients with HER2-positive breast carcinoma in situ 1. Trastuzumab (HER2-Targeted Therapy): * Trastuzumab will be administered intravenously at a standard dosage based on the patient's body weight. The initial dose will be a loading dose followed by maintenance doses every three weeks, as per clinical guidelines for HER2-positive breast cancer treatment. * The therapy targets the HER2 receptor to inhibit tumor growth and improve response rates. 2. Taxane (Chemotherapy): * A taxane-based chemotherapeutic agent (e.g., paclitaxel or docetaxel) will be administered intravenously. The specific agent, dosage, and schedule will follow standard protocols used in the neoadjuvant setting for HER2-positive breast cancer. * Taxanes work by disrupting microt

Drug: Trastuzumab combined with taxane neoadjuvant therapy

Interventions

Trastuzumab combined with taxane neoadjuvant therapy DRUG

Trastuzumab combined with taxane neoadjuvant therapy

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed breast carcinoma in situ (female, 18 to 70 years old);
• Breast mass ≥2cm, and in situ cancer pathology confirmed HER2 positive (definition: immunohistochemical results 3+ or in situ hybridization results positive);
• No evidence of distant transfer;
• Have not received any previous cancer treatment;
• Imaging examination showed at least one measurable lesion within 2 weeks before enrollment;
• Left ventricular ejection fraction (LVEF) was measured by echocardiography ≥50%;
• Previous treatment-related toxicity should be alleviated to NCI CTCAE (version 5.0) ≤1 degree, AST and ALT≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;
• Liver and kidney function tests are basically normal:
• Total bilirubin (TBIL) ≤3× upper limit of normal (ULN),
• Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤2.5×ULN (patients with liver metastasis ≤5xULN),
• Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min;
• Adequate bone marrow functional reserve:
• White blood cell count (WBC) ≥3.0×10\^9 / L,
• Neutrophil count (ANC) ≥1.5×10\^9 / L,
• Platelet count (PLT) ≥70×10\^9 / L

You may not qualify if:

• Metastatic breast cancer (stage IV);
• History of invasive breast cancer, or prior systemic treatment to treat or prevent breast cancer;
• Previous or concurrent malignant diseases, except skin basal cell carcinoma or cervical cancer in situ;
• Patients with severe heart disease or discomfort that is not expected to tolerate chemotherapy, including but not limited to: fatal arrhythmias or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular disease, transmural myocardial infarction shown by electrocardiogram, uncontrolled hypertension;
• Insufficient bone marrow or kidney function, liver function impairment;
• Grade 2 or more severe peripheral neuropathy;
• Patients with thrombocytopenia, neutropenia, anemia, hypokalemia, and elevation of alanine aminotransferase or aspartate aminotransferase above CTCAE Level 1;
• Patients who are known to be allergic to the active ingredient or other ingredient of the investigational drug;
• Had received radiotherapy, chemotherapy, endocrine therapy, or was participating in any interventional drug clinical trial within 4 weeks prior to enrollment;
• Pregnant or lactating women, women of childbearing age who refused to use effective contraception during the study period;
• Any other conditions that the investigator considers the patient unfit to participate in the study, concomitant diseases or conditions that may interfere with study participation, or any serious medical disorder that may affect the safety of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrollable infection, active hepatitis B virus infection).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)