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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian Suppression and aromatase inhibitors | Experimental | 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. |
|
| Ovarian Suppression and tamoxifen | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin | Drug |
| ||
| Tamoxifen |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Invasive Breast Cancer Recurrence-Free Interval(BCFI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Ying, doctor | Contact | 020-28823235 | linying3@mail.sysu.edu.cn | |
| Chen R Ping, bachelor | Contact | 13533242895 | ruping089@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Active, not recruiting | Beijing | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24872111 | Background | Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9. | |
| 26211827 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23. |
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| Drug |
|
| Aromatase Inhibitors | Drug |
|
| Leuprolide | Drug |
|
|
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.
| 5 years |
| Adverse Effects Rate | 5 years |
| Peking University First Hospital |
| Active, not recruiting |
| Beijing |
| China |
| Dongguan People's Hospital | Recruiting | Dongguan | China |
|
| GuangDong Hospital Of Traditional Chinese Medicine | Recruiting | Guangzhou | China |
|
| Guangdong People's Hospital | Active, not recruiting | Guangzhou | China |
| Guangdong Provincial Women and Children's Hospital | Recruiting | Guangzhou | China |
|
| Guangzhou First Municipal People's Hospital | Recruiting | Guangzhou | China |
|
| Guangzhou Women and Childrens Medical Center | Recruiting | Guangzhou | China |
|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
|
| Guilin TCMhospital of China | Recruiting | Guilin | China |
|
| Zhejiang Provincial People's Hospital | Active, not recruiting | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | China |
|
| Yunnan Cancer Hospital | Active, not recruiting | Kunming | China |
| Maoming People's Hospital | Recruiting | Maoming | China |
|
| The first Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | China |
|
| The Affiliated Hospital of Qingdao University | Active, not recruiting | Qingdao | China |
| The First Affiliated Hospital of Wenzhou Medical University | Active, not recruiting | Wenzhou | China |
| Affiliated hospital of Guangdong Medicine College | Recruiting | Zhanjiang | China |
|
| Affiliated hospital of Guangdong Medicine College | Recruiting | Zhanjiang | China |
|
| Lian Jiang People' s Hospital | Recruiting | Zhanjiang | China |
|
| Henan Cancer Hospital | Active, not recruiting | Zhengzhou | China |
| Zhongshan People's Hospital | Recruiting | Zhongshan | China |
|
| The Fifth Affiliated Hospital Sun Yat-Sen University | Recruiting | Zhuhai | China |
|
| 17512856 | Background | LHRH-agonists in Early Breast Cancer Overview group; Cuzick J, Ambroisine L, Davidson N, Jakesz R, Kaufmann M, Regan M, Sainsbury R. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007 May 19;369(9574):1711-23. doi: 10.1016/S0140-6736(07)60778-8. |
| 24881463 | Background | Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1. |
| 25495490 | Background | Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D013629 | Tamoxifen |
| D047072 | Aromatase Inhibitors |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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