Clinical trial · Observational
The Efficacy and Safety of Neoadjuvant Trastuzumab Plus Taxane With and Without Pertuzumab Therapy
A Multicenter Chart Review Study for Evaluating The Efficacy and Safety of Neoadjuvant Trastuzumab Plus Taxane With and Without Pertuzumab Therapy in Locally Advanced HER2 Positive Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a Non-Interventional Study (NIS) with secondary data usage. It is designed as a multi-center retrospective cohort study in which the data of adult locally advanced HER2-positive breast cancer patients, who are treated with as neoadjuvant therapy, who underwent breast surgery in participating centers, were taken from hospital records. The source population is academic or community oncology centers treating patients with breast cancer from Turkey. The study population is planned to be the subgroup of breast cancer patients, who are treated with trastuzumab plus taxane with or without pertuzumab as neoadjuvant therapy, and underwent breast surgery at the participating centers. The study is anticipated to include approximately 1500 patients from 20 sites.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate Pathologic Complete Response (pCR) rate
- timeFrame
- 8 months
- description
- pCR is defined as the absence of residual invasive disease on H\&E evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).
Secondary outcomes (3)
- measure
- To evaluate 2 year Event-Free Survival (EFS)
- timeFrame
- 24 months
- description
- 2 year EFS events are defined from trastuzumab initiation as the first occurrence of one of; progression of disease that precludes surgery, local or distant recurrence or death to any cause in two years.
- measure
- To evaluate 2-year Invasive Disease-Free Survival (IDFS)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years old and over * Patients diagnosed as histologically confirmed (IHC score of 3+ and/or positive by ISH) locally advanced HER2-positive breast cancer with breast surgery. * Patients who received as neoadjuvant therapy. Exclusion Criteria: * Patients transferred from an other hospital should not be included, however, patients' data transferred to an other hospital will be collected till transfer time
References
Publications (0)
Data not yet available