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Search / Trial NCT04476485

Sj-subway, a Predictor for the Recurrence of High-risk Hormone Receptor-positive Breast That is Sensitive to Extended Endocrine Therapy

Launched by SHENGJING HOSPITAL · Jul 17, 2020

Trial Information

Current as of May 18, 2025

Recruiting

Keywords

Receptor, Estrogen Endocrine Therapy Aromatase Inhibitor

ClinConnect Summary

This clinical trial, called Sj-subway, is studying a potential way to predict the recurrence of high-risk hormone receptor-positive breast cancer in women. Hormone receptor-positive breast cancer is a type that responds well to hormone therapy, and many women undergo an initial 5 years of treatment. However, some patients remain at risk for the cancer returning even after this treatment ends. The researchers are exploring whether sj-subway, a specific marker found in breast cancer tissue, can help identify which patients may benefit from additional hormone therapy beyond the initial 5 years, potentially improving their outcomes while minimizing the side effects of extended treatment.

To participate in this trial, women aged 18 to 70 with early-stage hormone receptor-positive breast cancer who have completed 5 years of standard hormone therapy without any signs of cancer returning may be eligible. They should also have certain risk factors, such as larger tumor size or specific cancer cell characteristics. Participants will receive further evaluation based on sj-subway levels to determine if extended therapy is appropriate for them. This study aims to provide clearer guidance on treatment decisions for women at higher risk of recurrence.

Gender

FEMALE

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.

About Shengjing Hospital

Shengjing Hospital, affiliated with the China Medical University, is a leading medical institution dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on multidisciplinary collaboration, the hospital leverages its state-of-the-art facilities and a team of experienced healthcare professionals to conduct comprehensive studies aimed at improving patient outcomes. Shengjing Hospital is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring that all clinical trials are designed to enhance medical knowledge and provide safe, effective treatment options for diverse patient populations.

Locations

Changchun, Jilin, China

Shenyang, Liaoning, China

Shenyang, Liaoning, China

Shenyang, Liaoning, China

Shenyang, Liaoning, China

Shenyang, Liaoning, China

Harbin, Heilongjiang, China

Dalian, Liaoning, China

Shenyang, Liaoning, China

Panjin, Liaoning, China

Patients applied

0 patients applied

Trial Officials

Jin-Qi Xue

Principal Investigator

Shengjing Hospital

Xi Gu

Principal Investigator

Shengjing Hospital

Nan Niu

Principal Investigator

Shengjing Hospital

Tian-Hui Xia

Principal Investigator

Shengjing Hospital

Wei Tu

Principal Investigator

Fourth Affiliated Hospital of China Medical University

Hong Xu

Principal Investigator

Liaoning Cancer Hospital & Institute

Hao Zhang

Principal Investigator

Liaoning Cancer Hospital & Institute

Yuan-Xi Huang

Principal Investigator

Heilongjiang Cancer Hospital

Shao-Qiang Cheng

Principal Investigator

Heilongjiang Cancer Hospital

Bing-Shu Xia

Principal Investigator

Heilongjiang Cancer Hospital

Wen-Bin Guo

Principal Investigator

Dalian Municipal Central Hospital

Xue Jiang

Principal Investigator

Dalian Municipal Central Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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