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

NCT01779531 | Unknown DMC

• 1 other identifier: GGHBCRG
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Keywords

HER2-negative Luminal B breast cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 5 years after adjuvant chemotherapy

• 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.

  Within five years after adjuvant chemotherapy

Secondary Outcomes (1)

• Imaging evaluation after neoadjuvant chemotherapy

  within the 21 days after neoadjuvant chemotherapy

Other Outcomes (1)

• Baseline evaluation

  before the neoadjuvant chemotherapy

Study Arms (1)

pCR，XT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2 negative Luminal B subtype breast cancer patients

You may qualify if:

• 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%

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Guangdong Academy of Medical Sciences: lead
• Chinese Anti-Cancer Association: collaborator
• Guangzhou General Hospital of Guangzhou Military Command: collaborator
• Guangzhou First People's Hospital: collaborator

Study Sites (1)

Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue，whole blood

Study Officials

• Liao Ning, MD,PhD

  Guangdong Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Liao Ning, MD,PhD

CONTACT

13903054106; drliao_ning@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

CN (1)