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

This study is not yet open for participant recruitment.
Verified January 2013 by Guangdong Academy of Medical Sciences
Sponsor:
Collaborators:
Chinese Anti-Cancer Association
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First Municipal People’s Hospital
Information provided by (Responsible Party):
Liao Ning, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01779531
First received: January 24, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Phase III，Randomized ，Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guangdong Academy of Medical Sciences:

Primary Outcome Measures:
  • Disease free survival after adjuvant chemotherapy within five years [ Time Frame: Within 5 years after adjuvant chemotherapy ] [ Designated as safety issue: Yes ]
    Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.

  • Overall survival after adjuvant chemotherapy within five years [ Time Frame: Within five years after adjuvant chemotherapy ] [ Designated as safety issue: Yes ]
    Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.


Secondary Outcome Measures:
  • Imaging evaluation after neoadjuvant chemotherapy [ Time Frame: within the 21 days after neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Baseline evaluation [ Time Frame: before the neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]
    Baseline evaluation includes the issues of ECOG PS scores, primary tumor Imaging evaluation, evaluation and reserve of bone marrow and organ function evaluation.


Biospecimen Retention:   Samples Without DNA

tissue，whole blood


Estimated Enrollment: 640
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HER2 negative Luminal B subtype breast cancer patients

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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779531

Contacts
Contact: Liao Ning, MD,PhD 13903054106 drliao_ning@hotmail.com

Locations
China, Guangdong
Guangdong Academy of Medical Sciences Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wen Ling Zhu     13763316144     dearecho@msn.com    
Sponsors and Collaborators
Guangdong Academy of Medical Sciences
Chinese Anti-Cancer Association
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First Municipal People’s Hospital
Investigators
Study Director: Liao Ning, MD,PhD Guangdong Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Liao Ning, MD,PhD, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01779531     History of Changes
Other Study ID Numbers: GGHBCRG
Study First Received: January 24, 2013
Last Updated: January 28, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangdong Academy of Medical Sciences:
HER2-negative Luminal B breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013