Predicting recurrence in high-risk hormone receptor-positive breast cancer patients receiving extended endocrine therapy
Official title: A Newly Discovered Clinical Recurrence Predictor for High-risk Hormone Receptor-positive Breast Cancer: a Real Word Study
Run by Shengjing Hospital · NCT04476485 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Harbin, Heilongjiang and 11 other locations) |
| Status | Recruiting |
| Started | July 19, 2021 |
| Main results expected | December 31, 2021 |
| Study ends | December 31, 2026 |
| Registry record updated | July 20, 2021 |
| Trial ID | NCT04476485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a history of other malignancies or severe organ dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown success with extended endocrine therapy in similar patient populations, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 6 more locations
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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
- Email: angel-s205@163.com
- Phone: 18940254967
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.