Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

NCT07047755 | Not Yet Recruiting Phase 2

• 1 other identifier: HELEN-027
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Total pathological complete response (tpCR: ypT0-is，ypN0)

  At the time of surgery

Secondary Outcomes (4)

• iDFS

  Up to approximately 5 years

• EFS

  Up to approximately 5 years

• ORR

  Up to approximately 24 weeks after the first administration

• AEs

  From the first dose until 30 days after last dose

Study Arms (1)

Treatment group

EXPERIMENTAL

Trastuzumab Rezetecan; Pertuzumab

Drug: Trastuzumab Rezetecan; Drug: Pertuzumab

Interventions

Trastuzumab Rezetecan DRUG

Trastuzumab Rezetecan

Treatment group

Pertuzumab DRUG

Pertuzumab

Treatment group

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18-70 years;
• Histopathologically confirmed HER2 positive breast cancer;
• Patients were diagnosed with stage II-III breast cancer;
• At least one measurable target lesion according to RECIST V1.1;
• ECOG performance status score of 0 to 1;
• Life expectancy ≥12 weeks;
• Adequate bone marrow reserve and organ system function reserve;
• Participants should be able and willing to comply with the study protocol requirement;

You may not qualify if:

• Breast cancer not histologically confirmed;
• Known inherited or acquired bleeding and thrombotic tendencies;
• Known allergy or contraindication to the study drug and its excipients;
• Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
• Concurrent receipt of any other form of anti-cancer therapy;
• History of a second primary malignancy, except for adequately treated skin cancer;
• Participation in other drug clinical trials within 4 weeks before enrollment;
• Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
• Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
• Uncontrolled or significant cardiovascular and cerebrovascular diseases;
• Subjects with known or suspected interstitial pneumonia;
• Presence of active hepatitis B, hepatitis C, liver cirrhosis;
• Pregnant or lactating female patients;
• History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenzhen Liu

CONTACT

+86-13603862755; liuzhenzhen73@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 28, 2031
• Last Updated: July 2, 2025

Record last verified: 2025-06