Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

November 2, 2015 updated by: Ying Fan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Triple negative breast cancer patients with high risk factor will be randomized to receive either zoledronic acid or observation after the completion of standard chemotherapy/radiotherapy. Recurrence status will be followed and Disease free survival will be compared. Overall survival is the secondary endpoint.

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Phase 3

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • •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.
  • Written informed consent

Exclusion Criteria:

  • •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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
zoledronic acid received
Drug: Zoledronic acid
NO_INTERVENTION: B
observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 3 years after last patient was enrolled
the time from randomization to the time of disease progression or relapse or death
3 years after last patient was enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years after last patient was enrolled
the time from randomization to the time of death
5 years after last patient was enrolled
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 28 days after last medication
up to 28 days after last medication

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Beijing Municipal Science & Technology Commission

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

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 3, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-039

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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