Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes

NCT ID: NCT07187752

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1039 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab+Pertuzumab+Chemotherapy

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

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

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

Pertuzumab

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

Chemotherapy chosen by the investigators.

Excision of tumor/mastectomy

Intervention Type: PROCEDURE

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

Interventions

Trastuzumab

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

Intervention Type: DRUG

Pertuzumab

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

Intervention Type: DRUG

Chemotherapy

Chemotherapy chosen by the investigators.

Intervention Type: DRUG

Excision of tumor/mastectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

QL1701 (A trastuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd); QL1209 (A pertuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd)

Eligibility Criteria

Inclusion Criteria

1. Age 18 - 75 years;

2. Eastern Cooperative Oncology Group (ECOG) score status 0-1.

3. 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);

4. HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization;

5. Known estrogen receptor (ER) and progesterone receptor (PgR) status.

6. Has adequate bone marrow, renal, hepatic and blood clotting functions.

7. Left ventricular ejection fraction (LVEF) ≥50 percent (%).

8. 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.

9. Willing to provide tissue for research purposes.

10. Volunteer to participate in this study and sign the informed consent.

Exclusion Criteria

1. Patients with stage IV metastatic breast cancer.

2. Bilateral invasive breast cancer;

3. Patients with breast cancer who have previously received anti-tumor therapy.

4. 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)];

5. Subjects had participated in clinical trials of other antineoplastic drugs within 4 weeks before the group;

6. Has uncontrolled or significant cardiovascular disease.

7. Allergy to any investigational drug or any ingredient or excipient in the drug;

8. Female subjects who are pregnant, lactating or plan to become pregnant during the study.

9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Linlin Wang, PhD, MD

Role: CONTACT

wanglinlinatjn@163.com

+86 13793187739

Jinming Yu, PhD, MD

Role: CONTACT

jn7984729@public.jn.sd.cn

+86 13806406293

Other Identifiers

QL-BC-QUPA-RWS-001

Identifier Type: -

Identifier Source: org_study_id