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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Hospital of Jilin University
RECRUITING
Changchun
Dalian Municipal Central Hospital
RECRUITING
Dalian
Cancer Hospital Affiliated to Harbin Medical University
RECRUITING
Harbin
Panjin Liaohe Oilfield Gem Flower Hospital
RECRUITING
Panjin
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
Liaoning Tumor Hospital & Institute
RECRUITING
Shenyang
People's Hospital of Liaoning Province
RECRUITING
Shenyang
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The Fourth Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Cai-Gang Liu, MD
angel-s205@163.com
18940254967
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
experimental group
If the expression of sj-subway in the surgical wax block is eligible, it is recommended but not mandatory that patients follow the guidelines to choose the appropriate extended endocrine therapy.
Sponsors
Leads: Shengjing Hospital

This content was sourced from clinicaltrials.gov