The objective of this study is to compare the curative effects in patients under the age of 35 with hormone receptor positive breast cancer and high recurrent risk factors including large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the differences of curative effects between different subtypes to provide direct evidence for treatments of young breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
680
Disease-Free Survival (DFS)
DFS is defined as the time between randomization and the date of the first occurrence of events as follow: local, regional recurrence or distant metastasis of invasive breast cancer, contralateral invasive breast cancer, or death due to any diseases. Patients who have not had disease progression or death at the end of follow-up (5 years) will be censored at the date last known to be alive and distant metastasis free. Subgroup analysis DFS of Luminal A and Luminal B breast cancer.
Time frame: 5 years
Overall Survival (OS)
The time from randomization to death due to any cause. Patients still alive at the end of follow-up (5 years) will be censored at the last known alive date.
Time frame: 5 years
Invasive Breast Cancer Recurrence-Free Interval(BCFI)
The time between randomization and the first occurrence of local, regional recurrence or distant metastasis of invasive breast cancer, or contralateral invasive breast cancer. Patients who have not had invasive breast cancer recurrence at the end of follow-up (5 years) will be censored at the date last known to be distant metastasis free.
Time frame: 5 years
Adverse Effects Rate
Time frame: 5 years
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
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ACTIVE_NOT_RECRUITINGDongguan People's Hospital
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RECRUITINGGuangDong Hospital Of Traditional Chinese Medicine
Guangzhou, China
RECRUITINGGuangdong People's Hospital
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ACTIVE_NOT_RECRUITINGGuangdong Provincial Women and Children's Hospital
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RECRUITINGGuangzhou First Municipal People's Hospital
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RECRUITINGGuangzhou Women and Childrens Medical Center
Guangzhou, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
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RECRUITINGSun Yat-sen University Cancer Center
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RECRUITING...and 15 more locations