Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women
NCT ID: NCT02914158
Last Updated: 2023-01-17
Study Results
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Basic Information
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RECRUITING
PHASE3
680 participants
INTERVENTIONAL
2016-03-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ovarian Suppression and aromatase inhibitors
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.
Goserelin
Aromatase Inhibitors
Leuprolide
Ovarian Suppression and tamoxifen
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.
Goserelin
Tamoxifen
Leuprolide
Interventions
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Goserelin
Tamoxifen
Aromatase Inhibitors
Leuprolide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
3. Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (≥1%);
4. Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have);
5. No distant metastasis;
6. Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at least one region of regional lymph node metastasis (including micrometastases);
7. Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targeted therapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Association guidelines and specifications version 2015 for diagnosis and treatment of breast cancer;
8. Indexes of hematology and biochemistry conform to following standards: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2xULN, TBIL, DBIL, CCr≤1.5xULN.
Exclusion Criteria
2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
3. Concurrent malignancies or history of non-breast malignancies within the 5 years prior to study entry, except for curatively treated basal cell and squamous cell carcinomas of the skin, carcinoma in situ of the cervix; peripheral nervous system disorders caused by diseases or history of obvious mental and central nervous system disorders;
4. Prior use of neo-adjuvant chemotherapy after a definite diagnosis;
5. Nervous system disorders caused by diseases or obvious mental disorder, which would affect patients right to consent and compliance, or make patients in critical condition;
6. Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes;
7. Cardiac illness with obvious abnormal EKG or clinical symptoms, namely congestive heart failure, coronary atherosclerotic heart disease with obvious symptoms, arrhythmia difficult to control by drugs, or history of myocardial infarction within the 12 months prior to study entry or class III/IV of cardiac function;
8. Concurrent treatment in another investigational trial;
9. Sensitivity or contraindication to any of the study medications.
35 Years
FEMALE
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Ying Lin
Vice Director of Department of Breast Surgery
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Peking University First Hospital
Beijing, , China
Dongguan People's Hospital
Dongguan, , China
GuangDong Hospital Of Traditional Chinese Medicine
Guangzhou, , China
Guangdong People's Hospital
Guangzhou, , China
Guangdong Provincial Women and Children's Hospital
Guangzhou, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
Guangzhou Women and Childrens Medical Center
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Guilin TCMhospital of China
Guilin, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Yunnan Cancer Hospital
Kunming, , China
Maoming People's Hospital
Maoming, , China
The first Affiliated Hospital of Guangxi Medical University
Nanning, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Affiliated hospital of Guangdong Medicine College
Zhanjiang, , China
Affiliated hospital of Guangdong Medicine College
Zhanjiang, , China
Lian Jiang People' s Hospital
Zhanjiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Zhongshan People's Hospital
Zhongshan, , China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, , China
Countries
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Central Contacts
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Facility Contacts
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Ailing Zhang
Role: primary
Qianjun Chen
Role: primary
Zhang A Qin
Role: primary
Li Zhao
Role: primary
Hongming Ma
Role: primary
Yao H Rui
Role: primary
Yuan Z Yu
Role: primary
Lehong Zhang
Role: primary
Rui Zhuo
Role: primary
Li Cai
Role: primary
Weixiong Yang
Role: primary
Jingcai Zhong
Role: primary
Li J Wen
Role: primary
Zhang Y Qi
Role: primary
Huang Heng
Role: primary
Feihai Ling
Role: primary
Hongyu Zhang
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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20160818GD
Identifier Type: -
Identifier Source: org_study_id
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