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Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer

Status

Active

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Zoledronic acid

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring zoledronic acid, triple-negative breast cancer, adjuvant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

zoledronic acid received

observation

Outcomes

Primary Outcome Measures

disease free survival

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

Secondary Outcome Measures

overall survival

the time from randomization to the time of death

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

Full Information

NCT ID

NCT02595138

First Posted

November 2, 2015

Last Updated

November 2, 2015

Sponsor

Chinese Academy of Medical Sciences

Collaborators

Beijing Municipal Science & Technology Commission

1. Study Identification

Unique Protocol Identification Number

NCT02595138

Brief Title

Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer

Keywords

zoledronic acid, triple-negative breast cancer, adjuvant treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

zoledronic acid received

Arm Title

Arm Type

No Intervention

Arm Description

observation

Intervention Type

Drug

Intervention Name(s)

Zoledronic acid

Primary Outcome Measure Information:

Title

disease free survival

Description

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

Time Frame

3 years after last patient was enrolled

Secondary Outcome Measure Information:

Title

overall survival

Description

the time from randomization to the time of death

Time Frame

5 years after last patient was enrolled

Title

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

Time Frame

up to 28 days after last medication

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

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