An interventional study of Trastuzumab and Pertuzumab in Breast Cancer, sponsored by Shandong Cancer Hospital and Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Shandong Cancer Hospital and Institute · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,039 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
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)
Chemotherapy chosen by the investigators.
Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.
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
Time frame: At surgery
Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Before surgery
Breast pathological complete response (bPCR) rate
It is defined as no invasive tumor cells in the breast examined by microscopy after primary tumor resection (ypT0/is).
Time frame: At surgery
Number of participants with adverse events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
Time frame: 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.
Tumor tissue samples are analyzed by gene expression analysis and genome sequencing to classify novel subtypes and compare the molecular characteristics with patients' clinical data.
Time frame: Up to approximately 2 years from study enrollment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Shandong Cancer Hospital and Institute