Actively Recruiting

Age: 18Years - 70Years
FEMALE
NCT04476485

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

Led by Shengjing Hospital · Updated on 2021-07-20

1000

Participants Needed

12

Research Sites

284 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hormone receptor-positive breast cancer accounts for about 70% of all breast cancers. Extended endocrine therapy with aromatase inhibitor is the current main treatment for hormone receptor-positive breast cancer. However, previous studies have shown a long-lasting risk of the recurrence of hormone receptor-positive breast cancer at early stage, and disease recurrence is considered inevitable only depending on a 5-year of adjuvant endocrine therapy. Therefore, extended endocrine therapy is considered as a possible measure to reduce the risk of recurrence. Numerous clinical studies have focused on extended endocrine therapy in patients with specific types of breast cancer. In 2017, the National Comprehensive Cancer Network (NCCN) updated the recommends for extended endocrine therapy with aromatase inhibitor, where postmenopausal early-stage breast cancer patients wo have high risk factors may be considered to be given an extended 5-year endocrine treatment with aromatase inhibitor after the initial 5-year treatment. In 2019, the Chinese Society of Clinical Oncology also suggested that postmenopausal hormone receptor-positive patients who have been well tolerated to the initial 5 years of adjuvant endocrine therapy can be given the extended endocrine therapy under some restrictions. However, extended endocrine therapy may also cause other risks in patients. Long-term tamoxifen treatment can significantly increase the incidence of adverse reactions such as endometrial cancer, thrombotic disease, and dyslipidemia, and long-term aromatase inhibitor treatment can also increase the incidence of osteoporosis, fractures, dyslipidemia, and hypertension. Although anti-cancer treatment can reduce cancer deaths, it may increase deaths due to cardiovascular diseases. An attempt has been proposed to find out an indicator that can effectively determine the necessity of extended endocrine therapy in such patients, not only improving the prognosis of breast cancer patients, but also reducing treatment-related side effects. The author's team recently discovered sj-subway, a possible factor with a long tubular structure in breast cancer lesions. The authors found that the higher expression of sj-subway indicates the worse patient's prognosis. So the positive expression of sj-subway may be a predictor of recurrence and metastasis in high-risk hormone receptor-positive patients. However, whether this predictor can be used clinically remains to be studied. This real-world study intends to analyze the difference in the clinical efficacy of extended endocrine therapy under different sj-subway expression in high-risk hormone receptor-positive breast cancer patients, and to explore whether sj-subway can screen out the patients who can benefit from extended endocrine therapy, thus providing a therapeutic help for hormone receptor-positive breast cancer patients.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Early-stage invasive breast cancer positive for estrogen receptor and/or progesterone receptor confirmed by pathology
  • Completed standard 5 years of endocrine therapy without recurrence or metastasis
  • Age between 18 and 70 years
  • Presence of at least one of the following: KI67 64 30%, tumor size > 2 cm, positive lymph nodes, histological grade III, vascular cancer thrombus, or HER-2 gene overexpression or amplification
Not Eligible

You will not qualify if you...

  • History of other malignancies
  • Severe abnormalities in major organs such as heart, liver, or kidney, or inability to tolerate extended treatment
  • Severe osteoporosis or dyslipidemia, or inability to tolerate endocrine therapy
  • Participation in other clinical trials

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China, 150081

Actively Recruiting

2

The Second Hospital of Jilin University

Changchun, Jilin, China, 130041

Actively Recruiting

3

Dalian Municipal Central Hospital

Dalian, Liaoning, China, 116033

Actively Recruiting

4

Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, China, 124010

Actively Recruiting

5

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

6

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

7

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

8

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

9

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110032

Actively Recruiting

10

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China, 110042

Actively Recruiting

11

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

Actively Recruiting

12

People's Hospital of Liaoning Province

Shenyang, Liaoning, China

Actively Recruiting

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Research Team

C

Cai-Gang Liu, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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