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NCT Number: NCT01144572

Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
  • Undergoing upfront AIs adjuvant treatment within 7 days.

Exclusion criteria

  • Patients who disagree to participate this study
  • Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements.
  • The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.

Treatment and study plan

Primary outcomes

  1. The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.

    Time frame: 24 months

Secondary outcomes

  1. The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months

    Time frame: 6-18 months

  2. The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months

    Time frame: 6-18 months

  3. The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months.

    Time frame: 6-18 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Acronym: BC Qol NIS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 15, 2010
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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