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Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer

NCT ID: NCT01662128

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xeloda

Xeloda

Group Type EXPERIMENTAL

Xeloda

Intervention Type DRUG

Xeloda as Adjuvant Therapy

Interventions

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Xeloda

Xeloda as Adjuvant Therapy

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhang jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Zhang, Professor

Role: STUDY_CHAIR

Tianjin Cancer Hospital

Locations

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Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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ZHANG SHENG, DOCTOR

Role: primary

ZHANG SHENG, DORTOR

Role: backup

Other Identifiers

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xeloda

Identifier Type: -

Identifier Source: org_study_id