CClinicalTrials.gg
Sign In
Status unknownNCT01779531Updated Jan 30, 2013

Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients

An observational study in Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, sponsored by Guangdong Academy of Medical Sciences. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-30.

Sponsored by Guangdong Academy of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
640
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.

Read the detailed description

Individualized treatment of breast cancer has become one of the main directions in the clinical and research areas of breast cancer,and the individualized treatment of the estrogen receptor(ER) positive patients which covered 65% of total cases is of vital importance. Historical research showed that among the ER-positive and HER2-negative breast cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from chemotherapy,compared with the Luminal A breast cancer with Ki67\<14%. And the results of our previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence whether switching to Anthracycline-based post operative protocol can benefit them.So that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2 negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and OS of two subgroup.

02

Conditions studied

  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Browse trials for

Keywords

  • HER2-negative Luminal B breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 640 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Guangdong Academy of Medical Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HER2 negative Luminal B subtype breast cancer patients

Eligibility criteria

Inclusion Criteria:

  • Chinese population surgery patients with invasive breast cancer；
  • Stage II-III；
  • ER positive；
  • HER2 negative；
  • Ki67≥14%；
  • Aged between 18 and 70 years old；
  • The maximum diameter of the primary tumor greater than 1cm；
  • ECOG score 0-1 points； -Have adequate baseline bone marrow and organ function reserve : absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3 hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular ejection fraction ( LVEF ) ≥ 50%

Exclusion Criteria: - Non - Chinese population of patients；

  • Non- invasive cancer patients;
  • Inflammatory Breast Cancer patients;
  • Metastatic breast cancer patients;
  • HER2 positive patients;
  • Ki67\<14% patients;
  • No adequateBaseline bone marrow or organ function reserve;
  • ECOG PS score ≥ 2 points;
  • Younger than 18 years of age or greater than 70 years old;
  • Already accepted therapy including chemotherapy , endocrine therapy or targeted therapy before neoadjuvant treatment;
  • HER2-positive patients with left ventricular ejection fraction less than 55 % can not receiving Herceptin;
  • Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
640 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • pCR，XT
06

What researchers measure

Primary outcomes

  1. Disease free survival after adjuvant chemotherapy within five years

    Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.

    Time frame: Within 5 years after adjuvant chemotherapy

  2. Overall survival after adjuvant chemotherapy within five years

    Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.

    Time frame: Within five years after adjuvant chemotherapy

Secondary outcomes

  1. Imaging evaluation after neoadjuvant chemotherapy

    After neoadjuvant chemotherapy,we should evaluate the status of patients as progress disease and then use the imaging evaluations as the proofs to plan their next therapeutic schedule or different grouping methods.

    Time frame: within the 21 days after neoadjuvant chemotherapy

Other outcomes

  1. Baseline evaluation

    Baseline evaluation includes the issues of ECOG PS scores, primary tumor Imaging evaluation, evaluation and reserve of bone marrow and organ function evaluation.

    Time frame: before the neoadjuvant chemotherapy

07

Study locations

1 site
  • Guangdong Academy of Medical Sciences
    Guangzhou, Guangdong 510080, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01779531
Lead sponsor
Guangdong Academy of Medical Sciences
Collaborators
Chinese Anti-Cancer Association, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou First People's Hospital
Responsible party
Liao Ning (MD,PhD, Guangdong Academy of Medical Sciences) — Principal investigator
First posted
Jan 30, 2013
Start date
Jan 2013
Primary completion
Jun 2014 (estimated)
Completion
Jun 2015 (estimated)
Last update
Jan 30, 2013

Study contacts

Liao Ning, MD,PhD
Contact
drliao_ning@hotmail.com
13903054106
Liao Ning, MD,PhD
study director · Guangdong Academy of Medical Sciences

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Guangdong Academy of Medical Sciences

Start the discussion