Clinical trial · Observational
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
The Efficiency for Patient With Stage II-III HR+/HER2+ Early Breast Cancer With Standard Neoadjuvant Therapy: a Retrospective, Multicenter Study in Real World Settings.
NCT05263570CI-TRIAL-00060825recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Stage II-III HR+/HER2+ Early Breast Cancer
- description
- Stage II-III HR+/HER2+ Early Breast Cancer
- interventionNames
- Drug: Standard Therapy
Primary outcomes (1)
- measure
- Total pathological complete response (tpCR)
- timeFrame
- through study completion, an average of 1 year
- description
- tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Secondary outcomes (2)
- measure
- Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years or older * HR+/HER2- breast cancer diagnosis based on local standards * Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time * Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP） * Complete medical history was available * Karnofsky Performance Status (KPS) Scale score ≥ 70 Exclusion Criteria: * Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy) * Pregnant or breast-feeding women * Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer * Those who have stage IV breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.