Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer (AETNBC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02089854 |
Recruitment Status : Unknown
Verified November 2016 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : March 18, 2014
Last Update Posted : December 2, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Breast Cancer | Drug: Toremifene; Anastrozole | Phase 4 |
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 |

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 |
- disease-free survival [ Time Frame: 5 years ]
- overall survival [ Time Frame: 5 year ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089854
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. |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT02089854 |
Other Study ID Numbers: |
PUMCH-breast-TNBC |
First Posted: | March 18, 2014 Key Record Dates |
Last Update Posted: | December 2, 2016 |
Last Verified: | November 2016 |
triple negative breast cancer estrogen receptor-beta endocrine therapy |
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 |