Breast CancerPhase 3ASPAITNCT02914158
Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women
A Phase 3 study testing Goserelin, Tamoxifen and Aromatase Inhibitors in people with Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 25 sites in China.
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… Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Goserelin, Tamoxifen and Aromatase Inhibitors
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 25 sitesChina
- Study dates
- 30 Mar 2016to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites, 17 recruiting
- Active, not recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
- Active, not recruiting
Peking University First Hospital
Beijing
- Recruiting
Dongguan People's Hospital
Dongguan
Ailing Zhang
- Recruiting
GuangDong Hospital Of Traditional Chinese Medicine
Guangzhou
Qianjun Chen
- Active, not recruiting
Guangdong People's Hospital
Guangzhou
- Recruiting
Guangdong Provincial Women and Children's Hospital
Guangzhou
Zhang A Qin
- Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou
Li Zhao
- Recruiting
Guangzhou Women and Childrens Medical Center
Guangzhou
Hongming Ma
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Yao H Rui
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Yuan Z Yu
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Lehong Zhang
- Recruiting
Guilin TCMhospital of China
Guilin
Rui Zhuo
- Active, not recruiting
Zhejiang Provincial People's Hospital
Hangzhou
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
Li Cai
- Active, not recruiting
Yunnan Cancer Hospital
Kunming
- Recruiting
Maoming People's Hospital
Maoming
Weixiong Yang
- Recruiting
The first Affiliated Hospital of Guangxi Medical University
Nanning
Jingcai Zhong
- Active, not recruiting
The Affiliated Hospital of Qingdao University
Qingdao
- Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
- Recruiting
Affiliated hospital of Guangdong Medicine College
Zhanjiang
Li J Wen
- Recruiting
Affiliated hospital of Guangdong Medicine College
Zhanjiang
Zhang Y Qi
- Recruiting
Lian Jiang People' s Hospital
Zhanjiang
Huang Heng
- Active, not recruiting
Henan Cancer Hospital
Zhengzhou
- Recruiting
Zhongshan People's Hospital
Zhongshan
Feihai Ling
- Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai
Hongyu Zhang
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Goserelin, Tamoxifen, Aromatase Inhibitors, Leuprolide
- Keywords
- breast cancer, ovarian function suppression (OFS), aromatase inhibitors（AIs）, tamoxifen（TAM）
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
TamoxifenDrug
Aromatase InhibitorsDrug
LeuprolideDrug
Also called leuprolide acetate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Goserelin; Drug: Aromatase Inhibitors; Drug: Leuprolide |
| 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. Receives: Drug: Goserelin; Drug: Tamoxifen; Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
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.
Measured: 5 years
Adverse Effects Rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start30 Mar 2016
- Primary completion30 Dec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914158
- Sponsor's protocol ID
- 20160818GD
- Acronym
- ASPAIT
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2016
- Last updated
- 17 Jan 2023
- Results posted
- No
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.
PubMed 24872111Early 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.
PubMed 26211827LHRH-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.
PubMed 17512856Pagani 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.
PubMed 24881463Francis 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.
PubMed 25495490
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02914158
- Acronym / sponsor ID
- ASPAIT / 20160818GD
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ovarian function suppression (OFS), aromatase inhibitors（AIs）, tamoxifen（TAM）
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian Suppression and aromatase inhibitors | Experimental | Drug: Goserelin, Drug: Aromatase Inhibitors, Drug: LeuprolideOvarian 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 | Drug: Goserelin, Drug: Tamoxifen, Drug: LeuprolideOvarian 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. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goserelin | Drug | Ovarian Suppression and aromatase inhibitors, Ovarian Suppression and tamoxifen |
| Tamoxifen | Drug | Ovarian Suppression and tamoxifen |
| Aromatase Inhibitors | Drug | Ovarian Suppression and aromatase inhibitors |
| LeuprolideAlso: leuprolide acetate | Drug | Ovarian Suppression and aromatase inhibitors, Ovarian Suppression and tamoxifen |
Primary outcome
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Invasive Breast Cancer Recurrence-Free Interval（BCFI)
Time frame: 5 years
Adverse Effects Rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Background: PubMed 24872111Fan 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.
- Background: PubMed 26211827Early 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.
- Background: PubMed 17512856LHRH-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.
- Background: PubMed 24881463Pagani 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.
- Background: PubMed 25495490Francis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goserelin, Tamoxifen and Aromatase Inhibitors in people with Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Ying, doctor (020-28823235, linying3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914158, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.