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Not yet recruiting NCT07187752

Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trastuzumab, Pertuzumab, Chemotherapy, Excision of tumor/mastectomy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective and Multicenter Clinical Study to Identify the Molecular Characterization and Subtypes in Patients With HER2-positive Breast Cancer Receiving Neoadjuvant Trastuzumab and Pertuzumab.

Overview

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.

Interventions

  • Drug Trastuzumab
    Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks)
  • Drug Pertuzumab
    Pertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks)
  • Drug Chemotherapy
    Chemotherapy chosen by the investigators.
  • Procedure Excision of tumor/mastectomy
    Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.

Primary outcome measures

  • Total pathological complete response (tpCR) rate [Time frame: At surgery]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: Before surgery]
  • Breast pathological complete response (bPCR) rate [Time frame: At surgery]
  • Number of participants with adverse events (AEs) [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. [Time frame: Up to approximately 2 years from study enrollment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07187752 · QL-BC-QUPA-RWS-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗