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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
Sponsor:
Information provided by (Responsible Party):
Ying Lin, First Affiliated Hospital, Sun Yat-Sen University

Study Description
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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
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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

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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:

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

Locations
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Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
More Information
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Publications:

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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
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:
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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