NCT04045522

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 13, 2019

Last Update Submit

July 18, 2021

Conditions

Breast Cancer

Keywords

triple-negative breast cancerzoledronic acidreal-world study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Disease-free survival

    5 years

  • Overall survival

    5 years

  • Incidence of osteoporosis

    5 years

  • Incidence of bone-related events

    5 years

  • Incidence of other distant organ metastasis-related events

    5 years

Interventions

Zoledronic AcidDRUG

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.

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • pregnant or lactating women
  • those allergic to bisphosphonates
  • those who are participating in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

People's Hospital of Liaoning Province

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Caigang Liu

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Gu

CONTACT

86-18940255116jadegx@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department director

Study Record Dates

First Submitted

July 13, 2019

First Posted

August 5, 2019

Study Start

September 1, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2022

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CN(3)