Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes

NCT07187752 | Not Yet Recruiting

• 1 other identifier: QL-BC-QUPA-RWS-001
• Study Type: interventional
• Target: 1,039
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (tpCR) rate

  The pathological complete response rate described as the absence of invasive tumor cells in the breast and ipsilateral axillary lymph nodes upon microscopic examination following

  At surgery

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Before surgery

• Breast pathological complete response (bPCR) rate

  At surgery

• Number of participants with adverse events (AEs)

  Assessed every 2 cycles of neoadjuvant therapy prior to surgery, up to approximately 30 days after the last neoadjuvant treatment.

• Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes.

  Up to approximately 2 years from study enrollment

Study Arms (1)

Trastuzumab+Pertuzumab+Chemotherapy

EXPERIMENTAL

Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery.

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Chemotherapy; Procedure: Excision of tumor/mastectomy

Interventions

Trastuzumab DRUG

Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks)

Also known as: QL1701 (A trastuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd)

Trastuzumab+Pertuzumab+Chemotherapy

Pertuzumab DRUG

Pertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks)

Also known as: QL1209 (A pertuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd)

Trastuzumab+Pertuzumab+Chemotherapy

Chemotherapy DRUG

Chemotherapy chosen by the investigators.

Trastuzumab+Pertuzumab+Chemotherapy

Excision of tumor/mastectomy PROCEDURE

Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.

Trastuzumab+Pertuzumab+Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Age 18 - 75 years;
• Eastern Cooperative Oncology Group (ECOG) score status 0-1.
• Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0);
• HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization;
• Known estrogen receptor (ER) and progesterone receptor (PgR) status.
• Has adequate bone marrow, renal, hepatic and blood clotting functions.
• Left ventricular ejection fraction (LVEF) ≥50 percent (%).
• Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 7 months. Negative serum or urine pregnancy test within 7 days before study enrollment.
• Willing to provide tissue for research purposes.
• Volunteer to participate in this study and sign the informed consent.

You may not qualify if:

• Patients with stage IV metastatic breast cancer.
• Bilateral invasive breast cancer;
• Patients with breast cancer who have previously received anti-tumor therapy.
• Occurred or present with other malignant tumors within 5 years. Patients with the following two conditions can be enrolled: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\];
• Subjects had participated in clinical trials of other antineoplastic drugs within 4 weeks before the group;
• Has uncontrolled or significant cardiovascular disease.
• Allergy to any investigational drug or any ingredient or excipient in the drug;
• Female subjects who are pregnant, lactating or plan to become pregnant during the study.
• Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Long-Term Synaptic Depression; pertuzumab; Drug Therapy; Mastectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Linlin Wang, PhD, MD

CONTACT

+86 13793187739; wanglinlinatjn@163.com

Jinming Yu, PhD, MD

CONTACT

+86 13806406293; jn7984729@public.jn.sd.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share