Study on Bisphosphonates Targeting Triple-negative Breast Cancer

July 18, 2021 updated by: Caigang Liu, Shengjing Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • ShengJing Hospital Of China Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Tumor Hospital & Institute
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • People's Hospital of Liaoning Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with triple-negative breast cancer who received treatment in Shengjing Hospital of China Medical University, China.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response time
Time Frame: 5 years
Pathologic complete response is defined as no residual invasive tumor cells in the breast and axillary lymph nodes
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5 years
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
Overall survival
Time Frame: 5 years
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
Incidence of osteoporosis
Time Frame: 5 years
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
Incidence of bone-related events
Time Frame: 5 years
Incidence of bone pain, fracture and other bone related events.
5 years
Incidence of other distant organ metastasis-related events
Time Frame: 5 years
Incidence of metastasis to other distant organs such as the lung, liver, bone marrow, brain and ovary.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Collaborators

The People's Hospital of Liaoning Province
Liaoning Tumor Hospital & Institute

Investigators

  • Principal Investigator: Caigang Liu, Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shengjing_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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