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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02914158

Collaborator

(none)

680

Enrollment

Locations

Arms

116

Duration (Months)

27.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Apr 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2025

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

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) [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) [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) [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 [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	China
2	Peking University First Hospital	Beijing	China
3	Dongguan People's Hospital	Dongguan	China
4	GuangDong Hospital Of Traditional Chinese Medicine	Guangzhou	China
5	Guangdong People's Hospital	Guangzhou	China
6	Guangdong Provincial Women and Children's Hospital	Guangzhou	China
7	Guangzhou First Municipal People's Hospital	Guangzhou	China
8	Guangzhou Women and Childrens Medical Center	Guangzhou	China
9	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	China
10	Sun Yat-sen University Cancer Center	Guangzhou	China
11	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	China
12	Guilin TCMhospital of China	Guilin	China
13	Zhejiang Provincial People's Hospital	Hangzhou	China
14	Harbin Medical University Cancer Hospital	Harbin	China
15	Yunnan Cancer Hospital	Kunming	China
16	Maoming People's Hospital	Maoming	China
17	The first Affiliated Hospital of Guangxi Medical University	Nanning	China
18	The Affiliated Hospital of Qingdao University	Qingdao	China
19	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	China
20	Affiliated hospital of Guangdong Medicine College	Zhanjiang	China
21	Affiliated hospital of Guangdong Medicine College	Zhanjiang	China
22	Lian Jiang People' s Hospital	Zhanjiang	China
23	Henan Cancer Hospital	Zhengzhou	China
24	Zhongshan People's Hospital	Zhongshan	China
25	The Fifth Affiliated Hospital Sun Yat-Sen University	Zhuhai	China