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Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer (AETNBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02089854
Recruitment Status : Recruiting
First Posted : March 18, 2014
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is a prospective multi-center randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of adjuvant endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients) /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at least five years. The disease free survival(DFS) and overall survival(OS) between endocrine group and observation group will be compared to evaluate the effectiveness.

Condition or disease Intervention/treatment Phase
Female Breast Cancer Drug: Toremifene; Anastrozole Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Adjuvant Endocrine Therapy for Operable ER-beta Positive, ER-alpha/PR Negative, Her-2 Negative Breast Cancer Patients
Study Start Date : November 2014
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: endocrine therapy
toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients
Drug: Toremifene; Anastrozole
Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
No Intervention: observation

Outcome Measures

Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients signed the written informed consent.
  • The patients present with histologically proven operable invasive breast cancers without distant metastasis.
  • The breast tumor's positive ER/PR rate is <1%, and positive ER-beta rate is ≥1% by immuno-histochemistry(IHC).
  • The patients have no history of neoadjuvant hormone therapy.
  • The patients' Karnofsky performance score ≥70%.
  • Female patient who is ≥ 18yrs, and ≤ 80yrs.
  • The patients are non-pregnant, and disposed to practice contraception during the whole trial.
  • The patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.
  • The patients underwent chemotherapy, radiation therapy after surgery according to the 2013 NCCN guideline.
  • The results of patients' blood tests are as follows:

Hb≥90g/L; WBC≥4.0×109/L; Neutrophils≥1.5×109/L; Plt≥100×109/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); total bilirubin(TBIL) ≤ 1.5×ULN; Creatinine ≤ 1.25×ULN.

Exclusion Criteria:

  • The patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied).
  • The patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial.
  • The patients have history of neoadjuvant hormone therapy.
  • The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
  • The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
  • The patients are unwilling to stop any hormonal drug including hormone replacement therapy(HRT).
  • The patients can't understand the written informed consent; such as they have dementia.
  • The patients have allergic history or contraindication of toremifene/anastrozole.
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): NCT02089854

China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yanna Zhang, M.D.    +86 10 69152700    pumchzyn@sohu.com   
Principal Investigator: Qiang Sun, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02089854     History of Changes
Other Study ID Numbers: PUMCH-breast-TNBC
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016

Keywords provided by Peking Union Medical College Hospital:
triple negative breast cancer
estrogen receptor-beta
endocrine therapy

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents