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

The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01654367

Acronym

esozao

Enrollment

300

Registered

2012-07-31

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2012-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

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.

Interventions

DRUGZoledronic Acid and Aromatase Inhibitors

Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
therapeutic assessment	6 months	therapeutic assessment

Secondary

Measure	Time frame	Description
Adverse reactions and disease-free survival	2 years	Adverse reactions and disease-free survival

Other

Measure	Time frame	Description
Recurrence or death	5 years	Recurrence or death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026