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

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.

Study Overview

• Status: Unknown
• Conditions: Female Breast Cancer
• Intervention / Treatment: Drug: Toremifene; Anastrozole

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yanna Zhang, M.D.; Phone Number: +86 10 69152700; Email: pumchzyn@sohu.com
      • Principal Investigator: Qiang Sun, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: observation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 15, 2014
• First Submitted That Met QC Criteria: March 15, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: triple negative breast cancer; endocrine therapy; estrogen receptor-beta
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Anastrozole; Toremifene
• Other Study ID Numbers: PUMCH-breast-TNBC