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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01662128

Enrollment

600

Registered

2012-08-10

Start date

2012-06-30

Completion date

2022-06-30

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer

Brief summary

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.

Detailed description

The investigators will 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.

Interventions

DRUGXeloda

Xeloda as Adjuvant Therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse reactions	6 months	The occurrence of adverse reactions and the number of cases

Secondary

Measure	Time frame	Description
Disease-free survival	5 years	Disease-free survival of 5 years

Other

Measure	Time frame	Description
Overall survival,recurrence or death	10 years	Overall survival,recurrence or death of 10 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026