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

Primary Purpose

Female Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Toremifene; Anastrozole
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Breast Cancer focused on measuring triple negative breast cancer, estrogen receptor-beta, endocrine therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

endocrine therapy

observation

Arm Description

toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival

Full Information

First Posted
March 15, 2014
Last Updated
November 30, 2016
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02089854
Brief Title
Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer
Acronym
AETNBC
Official Title
Evaluation of Adjuvant Endocrine Therapy for Operable ER-beta Positive, ER-alpha/PR Negative, Her-2 Negative Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Cancer
Keywords
triple negative breast cancer, estrogen receptor-beta, endocrine therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endocrine therapy
Arm Type
Experimental
Arm Description
toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients
Arm Title
observation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Toremifene; Anastrozole
Intervention Description
Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanna Zhang, M.D.
Phone
+86 10 69152700
Email
pumchzyn@sohu.com
First Name & Middle Initial & Last Name & Degree
Qiang Sun, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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