Evaluating TOP2α Expression in Breast Cancer Patients After Chemotherapy

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

This study is trying to see if the level of a protein called TOP2α in breast cancer patients after chemotherapy affects their chances of staying cancer-free and living longer.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Cyclophosphamide
• Locations: 1 site (Tianjin)
• Trial ID: NCT02506361 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the relationship between TOP2α expression and the effects of non-dose-dense chemotherapy in breast cancer patients. A total of 800 patients who have previously undergone chemotherapy will be enrolled, with half receiving anthracyclines followed by taxanes and the other half receiving regimens without taxanes. Tumor tissue samples will be collected for TOP2α assays, and participants will be followed for up to 10 years to assess disease-free survival and overall survival rates. The study seeks to identify how TOP2α expression correlates with long-term outcomes in these patients.

Who should consider this trial

Good fit: Ideal candidates are breast cancer patients aged 18 to 70 who have undergone chemotherapy and have detectable TOP2α in their tumor tissue.

Not a fit: Patients with metastatic breast cancer or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify biomarkers that predict treatment outcomes in breast cancer patients, leading to more personalized therapies.

How similar studies have performed: While there have been studies exploring TOP2α in breast cancer, this specific approach of correlating its expression with non-dose-dense chemotherapy outcomes is relatively novel.

Eligibility criteria

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. . TOP2α 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.

Where this trial is running

Tianjin

• Jin Zhang — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Jin Zhang, Pro.

Conditions Breast Cancer; TOP2α; anthracyclines; taxanes; non dose-dense chemotherapy