Evaluation of the Relationship of TOP2α Expression and Effect of Non Dose-dense Chemotherapy for Breast Cancer

NCT02506361 | Unknown DMC

• 1 other identifier: E2014168
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective、multicenter、non-comparative interventional case series. 800 breast cancer patients who have already received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy, and the other 400 patients who have received regiments containing no taxanes. Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay. Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α expression and 5- year or 10-year disease free survival(DFS) and overall survival（OS）will be identified in this study.

Conditions

Breast Cancer

Keywords

TOP2α; anthracyclines; taxanes; non dose-dense chemotherapy

Outcome Measures

Primary Outcomes (1)

• TOP2αexpressions of participants

  The TOP2αexpression levels of the 800 enrolled patients tissue samples will be assayed by immunohistochemistry

  one year

Secondary Outcomes (2)

• Disease Free Survival time of participants

  ten year

• Overall Survival time of participants

  ten year

Eligibility Criteria

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

Study Population

800 breast cancer patients who have already received chemotherapy prior to this study will be enrolled in the group, including 400 patients who have received the anthracyclines followed taxanes chemotherapy, and the other 400 patients have received regiments containing no taxanes.

You may qualify if:

• Signed and dated informed consent indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
• Invasive breast cancer confirmed by histology or cytology with the tumor complete resection.
• Patients without remote organs metastasis.
• The Ages of patients ≥ 18 years and ≤70 years.
• Patients with positive axillary lymph nodes, or negative axillary lymph nodes plus one of these conditions: Triple-negative breast cancer, HER- 2(+),Ki-67≥15%.
• The values of aspartate aminotransferase(AST),alanine aminotransferase(ALT), alkaline phosphatase(ALP), total bilirubin(TBIL), UREA, CREA were less than 2 times of upper limits of normal at the beginning of aromatase inhibitors（AIs） therapy.
• TOP2α is available to be detected in the primary tumour tissue.
• Patients received the regimens of anthracyclines followed Taxanes or containing no Taxanes non-dose dense chemotherapy suggested by the guidelines of National Comprehensive Cancer Network （NCCN) 2014.

You may not qualify if:

• Patients is in the period of pregnancy or lactation.
• Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.
• Previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.
• Presence of other life-threatening cancers.
• Any severe concomitant condition: uncontrolled cardiac disease or uncontrolled diabetes mellitus. et al.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Jin Zhang

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin Zhang, Pro.

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Jin Zhang, Pro.

CONTACT

86-022-23340123; zhangjin@tjmuch.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: July 23, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 23, 2015

Record last verified: 2015-05

Locations

CN (1)