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

Breast Cancer Clinical Trial

Official title:

Evaluation of the Relationship of TOP2α Expression and Effect of Anthracyclines Followed Taxanes or Contains no Taxanes Non Dose-dense Chemotherapy for Breast Cancer: a Prospective, Non-interventional, Multicentre Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506361
• Other study ID #: E2014168
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2015
• Last updated: July 21, 2015
• Start date: May 2015
• Est. completion date: October 2025

Study information

• Verified date: May 2015
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jin Zhang, Pro.
• Phone: 86-022-23340123
• Email: zhangjin[@]tjmuch.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

800 breast cancer patients who have received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy(Epirubicin 90 mg/m2 d1, Cyclophosphamide 600mg/m2 d1，21days/cycle, 4 cycles, followed by Docetaxel 75mg/m2,d1, 21days/cycle, 4 cycles;or paclitaxel：Epirubicin 90 mg/m2 d1 cyclophosphamide 600mg/m2 d1, 21day/cycle, 4 cycles, followed by paclitaxel 80mg/m2, weekly, 12 wks), and the other 400 patients who have received regiments containing no taxanes (FEC：5-FU 600mg/m2 d1,Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1, 21day/cycle, 6 cycles; or EC: Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1,21 day/cycle, 6 cycles).The patients will be enrolled in the groups within one month after chemotherapy.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

For inclusion in the study, subjects must fulfil all of the following criteria:

1. . 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.

2. . Invasive breast cancer confirmed by histology or cytology with the tumor complete resection.

3. . Patients without remote organs metastasis.

4. . The Ages of patients = 18 years and =70 years.

5. . 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%.

6. . 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.

7. . TOP2a is available to be detected in the primary tumour tissue.

8. . 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.

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. . Patients is in the period of pregnancy or lactation.

2. . Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.

3. . Previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.

4. . Presence of other life-threatening cancers.

5. . Any severe concomitant condition: uncontrolled cardiac disease or uncontrolled diabetes mellitus. et al.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Jin Zhang	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOP2aexpressions of participants	The TOP2aexpression levels of the 800 enrolled patients tissue samples will be assayed by immunohistochemistry	one year	No
Secondary	Disease Free Survival time of participants	Ten years followed-up survey will be conducted to identify the 5-year and 10-year Disease Free Survival time of participants.	ten year	No
Secondary	Overall Survival time of participants	Ten years followed-up survey will be conducted to identify the 5-year and 10-year Overall Survival time of participants.	ten year	No