A Phase 3 interventional study of Goserelin and Tamoxifen in Breast Cancer, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Recruiting at 25 sites in China. Open to female participants aged Up to 35 Years. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 680 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years. AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
Drug: Goserelin · Drug: Aromatase Inhibitors · Drug: Leuprolide
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years. Tamoxifen: 20mg oral for every day, for 5 years.
Drug: Goserelin · Drug: Tamoxifen · Drug: Leuprolide
Also known as: leuprolide acetate
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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First Affiliated Hospital, Sun Yat-Sen University