Clinical trial · Interventional
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy
Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment
- 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)
The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy. It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients. Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.
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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Low risk Capecitabine
- description
- Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine.
- interventionNames
- Drug: Capecitabine
- type
- NO_INTERVENTION
- label
- Low risk control
- description
- Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy.
- type
- EXPERIMENTAL
- label
- High risk Capecitabine
- description
- Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Invasive breast cancer at the first diagnosed 2. Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles 3. Neoadjuvant chemotherapy regimen should include anthracyclines and taxane 4. Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy 5. Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor) Exclusion Criteria: 1. Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy 2. Pregnant breast cancer 3. IHC or FISH test of primary tumor confirmed HER2 positive at anytime 4. Complete fewer than 6 cycles chemotherapy before surgery 5. Deficiency of surgery after neoadjuvant 6. Contraindication of chemotherapy or surgery
References
Publications (0)
Data not yet available