HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy

Official record

Identifier

NCT07848633

Recruiting locations

Locations are not included in the offline baseline for this record. Open the official record to see the current site list.

Interventions studied

- Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Target enrolment

65 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Not yet recruiting

First posted

Sep 30, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Aged ≥ 18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and reliable contraception must be used throughout the study treatment period.
2. Histopathologically confirmed invasive breast cancer, staged as stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2 (3+) confirmed by immunohistochemistry.
3. Have at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
4. No prior history of breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Voluntarily sign and date the written informed consent form.
7. Adequate organ function meeting the following laboratory criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5×10⁹/L, platelet count ≥ 100×10⁹/L, neutrophil count ≥ 1.5×10⁹/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 1.5× ULN; serum creatinine ≤ 1.5× ULN.
8. No myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) cardiac function class I; left ventricular ejection fraction (LVEF) ≥ 55% on echocardiography; cardiac biomarkers including cardiac troponin I (cTnI) and B-type natriuretic peptide (BNP) within normal reference ranges.
9. Complete all required baseline laboratory and radiological examinations prior to neoadjuvant treatment initiation.
10. No difficulty in swallowing.
11. Complete and available clinical medical records.

Exclusion Criteria:

1. Male breast cancer or inflammatory breast cancer.
2. Metastatic breast cancer (Stage IV).
3. Concurrent malignancy or a history of any other malignant tumor within the past 5 years, except for adequately treated and controlled basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
4. Receiving concurrent anti-tumor therapy or participating in any other clinical trial.
5. Presence of severe non-malignant diseases that may affect patient compliance or pose potential safety risks.
6. Underwent major surgery within 4 weeks prior to study treatment initiation or planned to receive major surgery during the study period.
7. Received breast cancer-related radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major breast surgery within 4 weeks before treatment initiation; have current or prior exposure to HER2-targeted monoclonal antibodies or tyrosine kinase inhibitors (TKIs), including trastuzumab, pertuzumab, pyrotinib, neratinib, and lapatinib.
8. History of allergic reactions or contraindications to any component of the study drugs.
9. Presence of chronic diarrhea, intestinal obstruction, or any other disease that may affect drug administration and absorption.
10. Uncontrolled cardiac diseases or clinical symptoms, including NYHA class II or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
11. Dementia, cognitive impairment, or any psychiatric disorder that hinders the understanding and signing of informed consent.

Indexed under

Breast Cancer