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Status unknownNCT01662128Updated Aug 10, 2012

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

A Phase 2/3 interventional study of Xeloda in Breast Cancer, sponsored by Tianjin Medical University. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2012-08-10.

Sponsored by Tianjin Medical University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 600 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Xeloda

    Xeloda

    Drug: Xeloda

Interventions

  • DrugXeloda

    Xeloda as Adjuvant Therapy

06

What researchers measure

Primary outcomes

  1. Adverse reactions

    The occurrence of adverse reactions and the number of cases

    Time frame: 6 months

Secondary outcomes

  1. Disease-free survival

    Disease-free survival of 5 years

    Time frame: 5 years

Other outcomes

  1. Overall survival,recurrence or death

    Overall survival,recurrence or death of 10 years

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Tianjin Cancer Hospital
    Tianjin, Tianjin Municipality 300060, China
    • ZHANG SHENG, DOCTOR · Contact · 86-022-23340123
    • ZHANG SHENG, DORTOR · Contact · 86-022-23340123
    • ZHANG JIN, PROFESSOR · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Jun 2014 and a completion of Jun 2022. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2012
First posted
Aug 10, 2012
Start
Jun 2012
Primary completionEst.
Jun 2014
CompletionEst.
Jun 2022
Last update
Aug 10, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01662128
Lead sponsor
Tianjin Medical University
Responsible party
Zhang jin (Professor, Tianjin Medical University) — Principal investigator
First posted
Aug 10, 2012
Start date
Jun 2012
Primary completion
Jun 2014 (estimated)
Completion
Jun 2022 (estimated)
Last update
Aug 10, 2012

Study contacts

Jin Zhang, Professor
study chair · Tianjin Cancer Hospital Airport Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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