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Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer

NCT ID: NCT01654367

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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Select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Detailed Description

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The investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoledronic Acid and Aromatase Inhibitors

Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Group Type EXPERIMENTAL

Zoledronic Acid and Aromatase Inhibitors

Intervention Type DRUG

Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy

Interventions

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Zoledronic Acid and Aromatase Inhibitors

Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Karnofsky≥70
2. Provision of informed consent
3. Pathological confirmation of breast cancer
4. Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy
5. Not previously received treatment with bisphosphonate
6. Laboratory criteria:

PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2\*ULN TBIL,DBIL,CCr≤1.5\*ULN
7. Surgery , radiotherapy and chemotherapy has finished

Exclusion Criteria

1. Pregnant of lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhang jin

Tianjin Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Zhang, Professor

Role: STUDY_CHAIR

Tianjin Cancer Hospital

Locations

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Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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ZHANG SHENG, DOCTOR

Role: primary

ZHANG SHENG, DORTOR

Role: backup

Other Identifiers

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jzhang2

Identifier Type: -

Identifier Source: org_study_id