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

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 |
- 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.
- 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 ]

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

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

Responsible Party: | Ying Lin, Vice Director of Department of Breast Surgery, First Affiliated Hospital, Sun Yat-Sen University |
ClinicalTrials.gov Identifier: | NCT02914158 |
Other Study ID Numbers: |
20160818GD |
First Posted: | September 26, 2016 Key Record Dates |
Last Update Posted: | August 2, 2017 |
Last Verified: | August 2017 |
breast cancer ovarian function suppression (OFS) aromatase inhibitors(AIs) tamoxifen(TAM) |
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 |