Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

Breast Cancer Clinical Trial

— ASPAIT  

Official title:

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen for Hormone Receptor-Positive Breast Cancer in Women Younger Than 35: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914158
• Other study ID #: 20160818GD
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2016
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Lin Ying, doctor
• Phone: 020-28823235
• Email: linying3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: December 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent;

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:

1. Pregnant or lactating women or women of childbearing potential reject contraceptive measures;

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Goserelin

• Tamoxifen

• Aromatase Inhibitors

• Leuprolide

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	5 years
Secondary	Adverse Effects Rate		5 years