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

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Zoledronic Acid and Aromatase Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT01654367

jzhang2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Zoledronic Acid and Aromatase Inhibitors

Experimental group

Description:

Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Treatment:

Drug: Zoledronic Acid and Aromatase Inhibitors