Zoledronic Acid as Adjuvant Treatment of Triple-negative... | NCT02595138

Studies
Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

NCT02595138

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 3, 2015Estimated

Enrollment

430Estimated

Phase

Phase 3

Conditions

Triple Negative Breast Cancer

Interventions

Zoledronic acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2018Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Nov 2, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Name	Class
Beijing Municipal Science & Technology Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

430Estimated

Label	Type	Description	Intervention Names
A	Experimental	zoledronic acid received	Drug: Zoledronic acid
B	No Intervention	observation

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid	Drug		A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
overall survival	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Binghe Xu, MD	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38979716	Derived	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.

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals