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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Xeloda

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Karnofsky ≥ 70
Provision of informed consent
Pathological confirmation of breast cancer and exclusion of other metastases.
Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis
The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy.
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:

Pregnant or lactation woman
Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ
Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy
History of organ transplantation
With mental disease
With severe infection or active gastrointestinal ulcers
With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
With heart disease
Experimental drug allergy

Sites / Locations

Tianjin Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xeloda

Arm Description

Xeloda

Outcomes

Primary Outcome Measures

Adverse reactions

The occurrence of adverse reactions and the number of cases

Secondary Outcome Measures

Disease-free survival

Disease-free survival of 5 years

Full Information

NCT ID

NCT01662128

First Posted

August 2, 2012

Last Updated

August 7, 2012

Sponsor

Tianjin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01662128

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Xeloda

Arm Type

Experimental

Arm Description

Xeloda

Intervention Type

Drug

Intervention Name(s)

Xeloda

Intervention Description

Xeloda as Adjuvant Therapy

Primary Outcome Measure Information:

Title

Adverse reactions

Description

The occurrence of adverse reactions and the number of cases

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

Disease-free survival of 5 years

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Overall survival,recurrence or death

Description

Overall survival,recurrence or death of 10 years

Time Frame

10 years

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Karnofsky ≥ 70 Provision of informed consent Pathological confirmation of breast cancer and exclusion of other metastases. Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy. 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: Pregnant or lactation woman Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy History of organ transplantation With mental disease With severe infection or active gastrointestinal ulcers With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) With heart disease Experimental drug allergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Zhang, Professor

Organizational Affiliation

Tianjin Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Tianjin Cancer Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ZHANG SHENG, DOCTOR

Phone

86-022-23340123

Ext

2901

First Name & Middle Initial & Last Name & Degree

ZHANG SHENG, DORTOR

Phone

86-022-23340123

Ext

2901

First Name & Middle Initial & Last Name & Degree

ZHANG JIN, PROFESSOR

12. IPD Sharing Statement

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

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