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

• ClinicalTrials.gov Identifier: NCT02089854
• Recruitment Status: Unknown
• First Posted: March 18, 2014
• Last Update Posted: December 2, 2016
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Peking Union Medical College Hospital

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

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes 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

Locations

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
• Other Study ID Numbers: PUMCH-breast-TNBC
• First Posted: March 18, 2014
• 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; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Toremifene; Anastrozole; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Bone Density Conservation Agents