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

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

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.

Study Overview

• Status: Unknown
• Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

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.

• Study Type: Observational
• Enrollment (Anticipated): 640

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

HER2 negative Luminal B subtype breast cancer patients

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pCR，XT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within the 21 days after neoadjuvant chemotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before the neoadjuvant chemotherapy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Estimate): January 30, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: HER2-negative Luminal B breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: GGHBCRG