Liver Safety Under Upfront Arimidex vs Tamoxifen (HEART)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00537771
First received: September 27, 2007
Last updated: December 20, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Anastrozole Drug: Tamoxifen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Incidence of Fatty Liver Disease [ Time Frame: At 48 weeks, 96 weeks, 144 weeks ] [ Designated as safety issue: Yes ]The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
Secondary Outcome Measures:
- Incidence of Abnormal Liver Function [ Time Frame: At 48 weeks, 96 weeks, 144 weeks ] [ Designated as safety issue: Yes ]The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
- Time to Treatment Failure [ Time Frame: Within 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 384 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Anastrozole (ARIMIDEX)
|
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
|
|
Active Comparator: 2
Tamoxifen
|
Drug: Tamoxifen
20 mg once daily oral dose
Other Name: NOLVADEX
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven HR+ invasive breast cancer
- Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
- Postmenopausal woman
Exclusion Criteria:
- clinical evidence of metastatic disease
- previous adjuvant hormonal therapy for breast cancer
- liver diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537771
Locations
| China, Fujian | |
| Research Site | |
| Fuzhou, Fujian, China | |
| China, Guangdong | |
| Research Site | |
| Guangzhou, Guangdong, China | |
| China, Guangxi | |
| Research Site | |
| Nanning, Guangxi, China | |
| China, Hubei | |
| Research Site | |
| Wuchang, Hubei, China | |
| Research Site | |
| Wuhan, Hubei, China | |
| China, Jiangsu | |
| Research Site | |
| Nanjing, Jiangsu, China | |
| China, Jilin | |
| Research Site | |
| Changchun, Jilin, China | |
| China, Liaoning | |
| Research Site | |
| Dalian, Liaoning, China | |
| China, Shandong | |
| Research Site | |
| Jinan, Shandong, China | |
| China, Shanghai | |
| Research Site | |
| Shanghai, Shanghai, China | |
| China, Shanxi | |
| Research Site | |
| Taiyuan, Shanxi, China | |
| Research Site | |
| Xian, Shanxi, China | |
| China, Sichuan | |
| Research Site | |
| Chengdu, Sichuan, China | |
| China, Yunnan | |
| Research Site | |
| Kunming, Yunnan, China | |
| China, Zhejiang | |
| Research Site | |
| Hangzhou, Zhejiang, China | |
| China | |
| Research Site | |
| Tianjin, China | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Vivian Gu | AstraZeneca |
| Study Chair: | Fengping Liang | AstraZeneca |
| Principal Investigator: | Prof. Wang Shenming | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00537771 History of Changes |
| Other Study ID Numbers: | D5392L00023 |
| Study First Received: | September 27, 2007 |
| Results First Received: | December 20, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Early Breast cancer adjuvant therapy hormone receptor |
hormonal therapy anastrozole tamoxifen |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013