Predicting recurrence in high-risk hormone receptor-positive breast cancer patients receiving extended endocrine therapy

A Newly Discovered Clinical Recurrence Predictor for High-risk Hormone Receptor-positive Breast Cancer: a Real Word Study

This study is trying to find out what factors can predict the chances of breast cancer coming back in high-risk patients who have finished their standard hormone therapy and are receiving extended treatment.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shengjing Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (Harbin, Heilongjiang and 11 other locations)
• Trial ID: NCT04476485 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify predictors for the recurrence of high-risk hormone receptor-positive breast cancer in patients who have completed a standard 5-year endocrine therapy regimen. It focuses on patients who meet specific high-risk criteria, such as tumor size and lymph node involvement, to evaluate the effectiveness of extended endocrine therapy with aromatase inhibitors. The study will analyze data from various hospitals to determine the long-term outcomes and recurrence rates in this patient population. By understanding these predictors, the study seeks to improve treatment strategies for patients at risk of recurrence.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-70 with early-stage invasive hormone receptor-positive breast cancer who have completed 5 years of standard endocrine therapy without recurrence.

Not a fit: Patients with a history of other malignancies or severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment plans that reduce the risk of breast cancer recurrence in high-risk patients.

How similar studies have performed: Previous studies have shown success with extended endocrine therapy in similar patient populations, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

* early-stage invasive breast cancer positive for estrogen receptor and / or progesterone receptor is pathologically confirmed;
* patients who have completed standard endocrine therapy for 5 years without recurrence and metastasis;
* 18-70 years old;
* patients with one of the following six manifestations: KI67 ≥ 30%; tumor size \> 2 cm; positive lymph nodes; histological grade III; vascular cancer thrombus; HER-2 gene overexpression or amplification.

Exclusion Criteria:

* with a history of other malignancies;
* patients who have severe abnormalities in important organs, such as the heart, liver, and kidney or who cannot be tolerant to extended treatment due to poor constitution;
* patients with severe osteoporosis or dyslipidemia, or those who cannot tolerate endocrine therapy ;
* patients who have participated in other clinical trials.

Where this trial is running

Harbin, Heilongjiang and 11 other locations

• Cancer Hospital Affiliated to Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China (Recruiting)
• Panjin Liaohe Oilfield Gem Flower Hospital — Panjin, Liaoning, China (Recruiting)
• Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Liaoning Tumor Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• People's Hospital of Liaoning Province — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Jin-Qi Xue — Shengjing Hospital
• Study coordinator: Cai-Gang Liu, MD

Conditions Breast Cancer; receptor, estrogen; endocrine therapy; aromatase inhibitor