Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women (ASPAIT)

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ClinicalTrials.gov Identifier: NCT02914158

Recruitment Status : Recruiting

First Posted : September 26, 2016

Last Update Posted : August 2, 2017

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Ying Lin, First Affiliated Hospital, Sun Yat-Sen University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Goserelin Drug: Tamoxifen Drug: Aromatase Inhibitors	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	680 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	April 2016
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2025

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Goserelin Goserelin acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Goserelin and aromatase inhibitors Goserelin: GnRH analogues goserelin 3.6 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
Active Comparator: Goserelin and tamoxifen Goserelin: GnRH analogues goserelin 3.6 mg administered intravenously every 28 days, for 5 years. Tamoxifen: 20mg oral for every day, for 5 years.	Drug: Goserelin Drug: Tamoxifen

Outcome Measures

Primary Outcome Measures :

Disease-Free Survival (DFS) [ Time Frame: 5 years ]
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.

Secondary Outcome Measures :

Overall Survival (OS) [ Time Frame: 5 years ]
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.
Invasive Breast Cancer Recurrence-Free Interval（BCFI) [ Time Frame: 5 years ]
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.
Adverse Effects Rate [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	up to 35 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent;
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (≥1%);
Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have);
No distant metastasis;
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);
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;
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:

Pregnant or lactating women or women of childbearing potential reject contraceptive measures;
History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
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;
Prior use of neo-adjuvant chemotherapy after a definite diagnosis;
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;
Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes;
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;
Concurrent treatment in another investigational trial;
Sensitivity or contraindication to any of the study medications.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914158

Contacts


Contact: Lin Ying, doctor	020-28823235	frostlin@hotmail.com
Contact: Chen R Ping, bachelor	13533242895	ruping089@163.com

Locations


China
Cancer Hospital Chinese Academy of Medical Sciences	Active, not recruiting
Beijing, China
Peking University First Hospital	Active, not recruiting
Beijing, China
Dongguan People's Hospital	Recruiting
Dongguan, China
Contact: Ailing Zhang
GuangDong Hospital Of Traditional Chinese Medicine	Recruiting
Guangzhou, China
Contact: Qianjun Chen
Guangdong People's Hospital	Active, not recruiting
Guangzhou, China
Guangdong Provincial Women and Children's Hospital	Recruiting
Guangzhou, China
Contact: Zhang A Qin
Guangzhou First Municipal People's Hospital	Recruiting
Guangzhou, China
Contact: Li Zhao
Guangzhou Women and Childrens Medical Center	Recruiting
Guangzhou, China
Contact: Hongming Ma
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Recruiting
Guangzhou, China
Contact: Yao H Rui
Sun Yat-sen University Cancer Center	Recruiting
Guangzhou, China
Contact: Yuan Z Yu
The Second Affiliated Hospital of Guangzhou Medical University	Recruiting
Guangzhou, China
Contact: Lehong Zhang
Guilin TCMhospital of China	Recruiting
Guilin, China
Contact: Rui Zhuo
Zhejiang Provincial People's Hospital	Active, not recruiting
Hangzhou, China
Harbin Medical University Cancer Hospital	Recruiting
Harbin, China
Contact: Li Cai
Yunnan Cancer Hospital	Active, not recruiting
Kunming, China
Maoming People's Hospital	Recruiting
Maoming, China
Contact: Weixiong Yang
The first Affiliated Hospital of Guangxi Medical University	Recruiting
Nanning, China
Contact: Jingcai Zhong
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
Contact: Li J Wen
Affiliated hospital of Guangdong Medicine College	Recruiting
Zhanjiang, China
Contact: Zhang Y Qi
Lian Jiang People' s Hospital	Recruiting
Zhanjiang, China
Contact: Huang Heng
Henan Cancer Hospital	Active, not recruiting
Zhengzhou, China
Zhongshan People's Hospital	Recruiting
Zhongshan, China
Contact: Feihai Ling
The Fifth Affiliated Hospital Sun Yat-Sen University	Recruiting
Zhuhai, China
Contact: Hongyu Zhang

Sponsors and Collaborators

First Affiliated Hospital, Sun Yat-Sen University

More Information

Publications:

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. Review.

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.

Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Láng 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, Láng 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.


Responsible Party:	Ying Lin, Vice Director of Department of Breast Surgery, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:	NCT02914158 History of Changes
Other Study ID Numbers:	20160818GD
First Posted:	September 26, 2016 Key Record Dates
Last Update Posted:	August 2, 2017
Last Verified:	August 2017

Keywords provided by Ying Lin, First Affiliated Hospital, Sun Yat-Sen University:


breast cancer ovarian function suppression (OFS) aromatase inhibitors（AIs） tamoxifen（TAM）

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Goserelin Aromatase Inhibitors Estrogen Antagonists Hormone Antagonists	Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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