Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

NCT02595138 | Unknown Phase 3

• 1 other identifier: CH-BC-039
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief Summary

Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.

Conditions

Triple Negative Breast Cancer

Keywords

zoledronic acid; triple-negative breast cancer; adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• disease free survival

  the time from randomization to the time of disease progression or relapse or death

  3 years after last patient was enrolled

Secondary Outcomes (2)

• overall survival

  5 years after last patient was enrolled

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up to 28 days after last medication

Study Arms (2)

A

EXPERIMENTAL

zoledronic acid received

Drug: Zoledronic acid

B

NO INTERVENTION

observation

Interventions

Zoledronic acid DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (≥ 18 years of age) with early stage breast cancer(stage II-III).
• Histological confirmation of estrogen and/or progesterone-receptor negative (ER-), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.
• ER/PR negative: nuclear reaction\< 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+
• axillary lymph node positive with other high risk factors: LVI, T\>5CM, Grade III
• Patients finish standard chemotherapy and/or radiotherapy
• ECOG performance status of 0,1
• Adequate bone marrow, hepatic, and renal function
• Adequate bone marrow and coagulation function as shown by:
• Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets\>100 x109/L;Hemoglobin (Hgb) \> 9.0g/dLINR \< 2
• Adequate liver function as shown by:
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5x ULN
• Total serum bilirubin \< 1.5 x ULN
• Adequate renal function as shown by:
• Serum creatinine\< 1.5 x ULN
• Fasting serum cholesterol \<300 mg/dL or 7.75 mmol/L and fasting triglycerides \<2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.

You may not qualify if:

• Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
• Any severe and/or uncontrolled medical conditions, eg. currently active infection
• Pregnant or lactating
• Patients unwilling to or unable to comply with the protocol

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Beijing Municipal Science & Technology Commission: collaborator

Related Publications (1)

• Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

  PMID: 38979716 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Binghe Xu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2023
• Last Updated: November 3, 2015

Record last verified: 2015-11