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

NCT01662128 | Unknown Phase 2 DMC

• 1 other identifier: xeloda
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse reactions

  The occurrence of adverse reactions and the number of cases

  6 months

Secondary Outcomes (1)

• Disease-free survival

  5 years

Other Outcomes (1)

• Overall survival,recurrence or death

  10 years

Study Arms (1)

Xeloda

EXPERIMENTAL

Xeloda

Drug: Xeloda

Interventions

Xeloda DRUG

Xeloda as Adjuvant Therapy

Xeloda

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky ≥ 70
• Provision of informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jin Zhang, Professor

  Tianjin Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 10, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2022
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

CN (1)