CClinicalTrials.gg
Status unknownNCT02012634MACROUpdated Nov 13, 2014

Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

An observational study in Breast Cancer, Capecitabine and Triple Negative Breast Cancer, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Xijing Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
340
Ages
18 Years to 70 Years
Sex
All
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Study summary

A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

Read the detailed description

Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and maintain for a whole year after the standard treatment in operable triple negative breast cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.

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Conditions studied

  • Breast Cancer
  • Capecitabine
  • Triple Negative Breast Cancer

Keywords

  • Breast Cancer
  • Capecitabine
  • Triple Negative Breast CancerTNBC(TNBC)
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In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 340 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Breast cancer patients of vascular endocrine surgery department in Xijing Hospital

Inclusion criteria

  • Female;
  • aged 18 - 70 years old;
  • Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
  • Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
  • No mass or microscopic tumor residue after surgery resection;
  • Initiate adjuvant chemotherapy within 30 days after surgery;
  • Axillary lymph node positive (including the sentinel lymph node positive and lymph node positive after axillary dissection), for example, axillary lymph node negative requires that primary tumor size must be greater than 1cm;
  • Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER \<10% tumor cells is defined as ER negative, PR \<10% positive tumor cells is defined as PR-negative, Her2 is 0\~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);
  • No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
  • Without peripheral neuropathy;
  • ECOG performance score is 0 or 1;
  • Postoperative recovery was good and an interval of at least one week since the surgery is necessary;
  • White blood cell count> 4 × 10\^9/l, neutrophil count> 2 × 10\^9/l, platelet count> 100 × 10\^9/l and hemoglobin 9g/dl);
  • ASAT and ALAT \<1.5 folds of the upper limit of normal values, alkaline phosphatase \<2.5 folds of the upper limit of normal values, total bilirubin \<1.5 folds of the upper limit of normal values;
  • Serum creatinine \<1.5 folds of the upper limit of normal value;
  • Women at childbearing age should take contraception measures during treatment;
  • Cardiac function: echocardiographic examination showed LEVF> 50%;
  • Informed consent form signed.

Exclusion criteria

Exclusion Criteria:

  • Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
  • Metastasis at any location;
  • Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
  • Any of ER, PR or Her-2 is positive;
  • Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
  • Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
  • Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
  • Already enrolled into other clinical trials;
  • Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF \<50% (echocardiography);
  • Suffering from severe cardiovascular and cerebrovascular diseases within six months before the randomization (such as: unstable angina, chronic heart failure, uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain vascular accident);
  • Known allergic to taxane and anthracycline agents;
  • Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
  • Pregnant and breast-feeding women;
  • Pregnancy test showed positive results before drug administration after enrolling in to the study; With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups (systematic evaluation is required before recruiting into this study);
  • Without personal freedom and independent civil capacity.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. PFS(Progression-free survival)

    PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death, assessed up to 3 years

    Time frame: Progression-free survival:time from the date of randomization until the date of disease progression,assessed up to 3 years

Secondary outcomes

  1. OS

    OS was defined as the time from the date of randomization until the date of any death occurred

    Time frame: time from the date of randomization until the date of any death occurred

  2. DDFS

    Time frame: time from the date of randomization until the date of any disease occurred

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Study locations

1 of 1 sites recruiting
  • Xijing Hospital ,Fourth Military Medical University
    Xi'an, Shaanxi 710032, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02012634
Lead sponsor
Xijing Hospital
Collaborators
Roche Pharma AG
Responsible party
LiNanlin,Ph.D, Chief Physician,Clinical Professor (The department of Vascular endocrine surgery, Xijing Hospital) — Principal investigator
First posted
Dec 16, 2013
Start date
Jan 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2018 (estimated)
Last update
Nov 13, 2014

Study contacts

Chen Cong, Master
Contact
congcongfeiyang@126.com
+86-13649294730
Nanlin Li, Doctor
principal investigator · Air Force Military Medical University, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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