Clinical trial · Interventional
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
Randomized Controlled Trials of Efficacy and Safety With Xeloda as Sequential Adjuvant Therapy After Chemotherapy of Anthracycline and/or Taxane in Breast Cancer of Triple Negative or HER-2 Positive or Axillary Lymph Node Metastasis ≥4
- 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)
Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.
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 |
|---|---|---|---|
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Xeloda
- description
- Xeloda
- interventionNames
- Drug: Xeloda
Primary outcomes (1)
- measure
- Adverse reactions
- timeFrame
- 6 months
- description
- The occurrence of adverse reactions and the number of cases
Secondary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5 years
- description
- Disease-free survival of 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Karnofsky ≥ 70 2. Provision of informed consent 3. Pathological confirmation of breast cancer and exclusion of other metastases. 4. Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis 5. The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy. 6. Laboratory criteria: PLT ≥ 100\*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2\*ULN TBIL,DBIL,CCr ≤ 1.5\*ULN Exclusion Criteria: 1. Pregnant or lactation woman 2. Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ 3. Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy 4. History of organ transplantation 5. With mental disease 6. With severe infection or active gastrointestinal ulcers 7. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 8. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) 9. With heart disease 10. Experimental drug allergy
References
Publications (0)
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