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
  Purpose

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 Intervention Phase
Female Breast Cancer
Drug: Toremifene; Anastrozole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: June 2014
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089854

Locations
China, Beijing
Peking Union Medical College Hospital Not yet 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

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02089854     History of Changes
Other Study ID Numbers: PUMCH-breast-TNBC
Study First Received: March 15, 2014
Last Updated: June 19, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Anastrozole
Toremifene
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014