Clinical trial · Observational
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer
Preoperative Systemic Therapy Versus Upfront Surgery in HER2 Positive Early Breast Cancer: a Prospective Nested Case-control Study in Real World
- 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)
Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%\~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been proved that PST could not improve either disease-free survival (DFS) or overall survival (OS) comparing with postoperatively systemic treatment in total population. We designed a real-world study to investigate the prognosis of anti-HER2 treatment combined with chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer
Conditions
Conditions (3)
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 |
| HER2 | — | UNRESOLVED | — |
| Preoperative Systemic Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative systemic treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PST
- description
- patient accepts preoperative systemic treatment as upfront strategy
- interventionNames
- Procedure: Preoperative systemic treatment
- label
- upfront surgery
- description
- patient accepts upfront surgery and run postoperative systemic treatment
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 5 years
- description
- as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. HER2 positive 2. early invasive breast cancer (cT1-3N0-1M0) 3. using one-year trastuzumab as anti-HER2 treatment Exclusion Criteria: 1. Exclude metastasis and recurrent breast cancer 2. using trastuzumab less than a year
References
Publications (1)
- DERIVEDYu X, Wang C, Zheng Y, Miao B, Hu J, Shao X, Sheng L, Lin J, Ding Y, Xuan H, Ding Y, Gong L, Feng W, Qin C, Chen D, Yu Y, Yang H. Preoperative Systemic Therapy Versus Upfront Surgery in HER2-Positive Breast Cancer in the Real World. Front Oncol. 2021 Jul 28;11:704842. doi: 10.3389/fonc.2021.704842. eCollection 2021. PMID 34395277