Clinical trial · Observational
Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients
A Phase III,Randomized ,Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy
- 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)
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.
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 |
|---|---|---|---|
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- pCR,XT
Primary outcomes (2)
- measure
- Disease free survival after adjuvant chemotherapy within five years
- timeFrame
- Within 5 years after adjuvant chemotherapy
- description
- Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
- measure
- Overall survival after adjuvant chemotherapy within five years
- timeFrame
- Within five years after adjuvant chemotherapy
- description
- Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.
Secondary outcomes (1)
- measure
- Imaging evaluation after neoadjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Chinese population surgery patients with invasive breast cancer; * Stage II-III; * ER positive; * HER2 negative; * Ki67≥14%; * Aged between 18 and 70 years old; * The maximum diameter of the primary tumor greater than 1cm; * ECOG score 0-1 points; -Have adequate baseline bone marrow and organ function reserve : absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3 hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular ejection fraction ( LVEF ) ≥ 50% Exclusion Criteria: - Non - Chinese population of patients; * Non- invasive cancer patients; * Inflammatory Breast Cancer patients; * Metastatic breast cancer patients; * HER2 positive patients; * Ki67\<14% patients; * No adequateBaseline bone marrow or organ function reserve; * ECOG PS score ≥ 2 points; * Younger than 18 years of age or greater than 70 years old; * Already accepted therapy including chemotherapy , endocrine therapy or targeted therapy before neoadjuvant treatment; * HER2-positive patients with left ventricular ejection fraction less than 55 % can not receiving Herceptin; * Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .
References
Publications (0)
Data not yet available