BENITIONSClinical Trial Intelligence

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

第3相 実施中(募集終了) NCT01272037

対象疾患Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma
第3相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数5,018 名
介入(薬剤)Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment
開始日2011年2月28日
完了日2023年2月1日
結果公開日2023年6月27日

概要

This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

Invasive Disease-Free Survival (IDFS)

5 years after randomization · percentage of participants

Chemo and Endocrine Therapy93.9 percentage of participants
Endocrine Therapy Alone89.0 percentage of participants
Chemo and Endocrine Therapy91.3 percentage of participants
Endocrine Therapy Alone91.9 percentage of participants
p-value0.35
Hazard Ratio (HR)1.02 (95% CI 0.98–1.05)

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