Study on Bisphosphonates Targeting Triple-negative Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter Prospective Real-world Study on Bisphosphonates Targeting Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045522
• Other study ID #: Shengjing_001
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2021
• Source: Shengjing Hospital
• Contact: Xi Gu
• Phone: 86-18940255116
• Email: jadegx[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Triple-negative breast cancer has a poor prognosis and lacks effective adjuvant treatment. A number of preclinical and clinical trials have shown that bisphosphonates have direct or indirect anti-tumor activity, and early use of bisphosphonate adjuvant therapy can prevent cancer recurrence and metastasis including bone metastasis and greatly improve the prognosis of cancer patients. Bisphosphonates have the advantages of low cost, low toxicity, and strong tolerance and can be used as an auxiliary treatment for triple-negative breast cancer. The preliminary study found that bisphosphonates can be chimeric with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, which can synergistically inhibit the in vitro tumor formation of cancer (such as non-small-cell lung cancer and breast cancer) cells and the growth of transplanted tumors. Therefore, the purpose of this multi-center prospective real-world study was to further investigate the effects of bisphosphonate adjuvant therapy on breast cancer.

Description:

Triple-negative breast cancer lacks expression of estrogen receptor, progesterone receptor, and proto-oncogene HER2 as shown by immunohistochemical examination. Its incidence accounts for 15-25% of that of all breast cancer types. This type of breast cancer lacks the opportunity of endocrine therapy and anti-human epidermal growth factor receptor 2 (HER2) therapy. The main currently available treatment is still chemotherapy. Some patients may choose anti-angiogenic therapy. The prognosis of triple-negative breast cancer is worse than that of other types of breast cancer due to fewer treatment options. Bisphosphonates used to treat bone metastasis of breast cancer have been shown to have anti-tumor effects and can be used as an adjuvant treatment for triple-negative breast cancer. The preliminary study found that bisphosphonates can be chimeric with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, which can synergistically inhibit the in vitro tumor formation of cancer (such as non-small-cell lung cancer and breast cancer) cells and the growth of transplanted tumors. The persistence of tumor stem cells is reportedly the root cause of malignant biological behavior of triple-negative breast cancer. Bisphosphonates may synergistically inhibit triple-negative breast cancer (stem) cells with existing molecular targeted drugs.

Although randomized controlled trials can provide highest-level clinical evidence, the test conditions should be strictly controlled, resulting in a small sample size and short follow-up time. However, real-world studies can include patients with multiple diseases and treatment strategies can be adjusted according to patient's needs and clinical conditions. In addition, a variety of interventions can be simultaneously used to accurately meet patient's needs, so that the research evidence is more clinically useful. Therefore, the purpose of this multi-center prospective real-world study was to investigate the significance of use of bisphosphonates as an adjuvant therapy against breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• developing breast cancer as confirmed by X-ray examination, and cancer tissue was negative for estrogen receptor, progesterone receptor and HER2

• presence of metastatic axillary lymph nodes

• standardized adjuvant therapy

• age over 55 years

Exclusion Criteria:

• pregnant or lactating women

• those allergic to bisphosphonates

• those who are participating in other trials

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Zoledronic Acid
Based on routine treatment, 4 mg zoledronic acid (Novartis Pharma Stein AG, Switzerland, registration No. H20140218) was intravenously administered, once every 3-4 weeks, for 1-2 years.

Locations

Country	Name	City	State
China	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning
China	People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (3)

Lead Sponsor	Collaborator
Shengjing Hospital	Liaoning Tumor Hospital & Institute, The People's Hospital of Liaoning Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response time	Pathologic complete response is defined as no residual invasive tumor cells in the breast and axillary lymph nodes	5 years
Secondary	Disease-free survival	It refers to the time from the start of the enrollment to the recurrence of the disease or the death of the patient due to disease progression.	5 years
Secondary	Overall survival	The length of time from either the date of diagnosis or the start of treatment for cancer, that patients diagnosed with the disease are still alive.	5 years
Secondary	Incidence of osteoporosis	Osteoporosis is considered to be present when a patient's bone density or bone mineral content is more than 2.5 standard deviations below the mean value of normal adult bone density.	5 years
Secondary	Incidence of bone-related events	Incidence of bone pain, fracture and other bone related events.	5 years
Secondary	Incidence of other distant organ metastasis-related events	Incidence of metastasis to other distant organs such as the lung, liver, bone marrow, brain and ovary.	5 years