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

NCT04476485 | Recruiting DMC

• 1 other identifier: ShengjingH 3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Breast Cancer

Keywords

receptor, estrogen; endocrine therapy; aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  the time from enrollment to relapse or death due to any reason.

  5 years after enrollment

Secondary Outcomes (3)

• Overall survival

  5 years after enrollment

• Incidence of contralateral breast cancer

  1, 2, 3, 4, and 5 years after enrollment

• Incidence of adverse events

  1, 2, 3, 4, and 5 years after enrollment

Study Arms (1)

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.

Other: endocrine therapy

Interventions

endocrine therapy OTHER

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. 1. For postmenopausal patients: Extend treatment with aromatase inhibitors 10 years: letrozole or anastrozole or exemestane. 2. For premenopausal patients: An initial 5 years tamoxifen treatment followed by additional 5 years extended tamoxifen treatment. Postmenopausals are treated with aromatase inhibitors 5 years. 3. For patients have completed ovarian function suppression plus initial 5-year aromatase inhibitor treatment: Menopausals: Aromatase inhibitors; Non-menopausals: 5 years of tamoxifen treatment or ovarian function suppression plus 5 years of aromatase inhibitor treatment. 4. For patients have completed ovarian function suppression plus initial 5-year tamoxifen treatment: Menopausals: Aromatase inhibitors for additional 5 years; Non-menopausals: Tamoxifen for additional 5 years.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The early-stage invasive breast cancer positive for estrogen receptor and / or progesterone receptor and have completed standard endocrine therapy for 5 years.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (12)

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

RECRUITING

Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, 124010, China

RECRUITING

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110032, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

People's Hospital of Liaoning Province

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin-Qi Xue

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Xi Gu

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Nan Niu

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Tian-Hui Xia

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Wei Tu

  Fourth Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Hong Xu

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Hao Zhang

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Yuan-Xi Huang

  Heilongjiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Shao-Qiang Cheng

  Heilongjiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Bing-Shu Xia

  Heilongjiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Wen-Bin Guo

  Dalian Municipal Central Hospital

  PRINCIPAL INVESTIGATOR

• Xue Jiang

  Dalian Municipal Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cai-Gang Liu, MD

CONTACT

18940254967; angel-s205@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: July 19, 2021
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CN (12)