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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT02089854
First received: March 15, 2014
Last updated: June 19, 2014
Last verified: June 2014

March 15, 2014
June 19, 2014
June 2014
April 2019   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02089854 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer
Evaluation of Adjuvant Endocrine Therapy for Operable ER-beta Positive, ER-alpha/PR Negative, Her-2 Negative Breast Cancer Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Female Breast Cancer
Drug: Toremifene; Anastrozole
Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
  • Experimental: endocrine therapy
    toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients
    Intervention: Drug: Toremifene; Anastrozole
  • No Intervention: observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
800
Not Provided
April 2019   (final data collection date for primary outcome measure)

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.
Female
18 Years to 80 Years
No
China
 
NCT02089854
PUMCH-breast-TNBC
Not Provided
Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Not Provided
Peking Union Medical College Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP