Clinical trial · Interventional
Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer
A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer
NCT02910050CI-TRIAL-00030880BETTERunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| Bicalutamide | Drug | Bicalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bicalutamide+ Aromatase Inhibitor
- description
- ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
- interventionNames
- Drug: Bicalutamide
- Drug: Aromatase Inhibitor
Primary outcomes (1)
- measure
- clinical benefit rate（CBR）
- timeFrame
- 24 weeks
- description
- Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.
Secondary outcomes (3)
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer * Metastatic or unresectable locally advanced disease * Age over 18 years * Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available） * Patient must have disease progression after treatment of an Aromatase inhibitor. * Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2 * Life expectancy over 3 months. * Measurable disease according to RECIST version 1.1 or only bone metastasis * Adequate hematological, hepatic function. * Voluntarily signed and dated written informed consent prior to any study specific procedure. Exclusion Criteria: * Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis * Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. * History of other primary malignancy * Resistant to steroidal or nonsteroidal aromatase Inhibitor
References
Publications (13)
- BACKGROUNDKuenen-Boumeester V, Van der Kwast TH, Claassen CC, Look MP, Liem GS, Klijn JG, Henzen-Logmans SC. The clinical significance of androgen receptors in breast cancer and their relation to histological and cell biological parameters. Eur J Cancer. 1996 Aug;32A(9):1560-5. doi: 10.1016/0959-8049(96)00112-8. PMID 8911118
- BACKGROUNDMangelsdorf DJ, Thummel C, Beato M, Herrlich P, Schutz G, Umesono K, Blumberg B, Kastner P, Mark M, Chambon P, Evans RM. The nuclear receptor superfamily: the second decade. Cell. 1995 Dec 15;83(6):835-9. doi: 10.1016/0092-8674(95)90199-x. No abstract available. PMID 8521507
- BACKGROUNDGrogg A, Trippel M, Pfaltz K, Ladrach C, Droeser RA, Cihoric N, Salhia B, Zweifel M, Tapia C. Androgen receptor status is highly conserved during tumor progression of breast cancer. BMC Cancer. 2015 Nov 9;15:872. doi: 10.1186/s12885-015-1897-2. PMID 26552477
- BACKGROUNDBrys M. Androgens and androgen receptor: do they play a role in breast cancer? Med Sci Monit. 2000 Mar-Apr;6(2):433-8. PMID 11208351
- BACKGROUNDWitzel I, Graeser M, Karn T, Schmidt M, Wirtz R, Schutze D, Rausch A, Janicke F, Milde-Langosch K, Muller V. Androgen receptor expression is a predictive marker in chemotherapy-treated patients with endocrine receptor-positive primary breast cancers. J Cancer Res Clin Oncol. 2013 May;139(5):809-16. doi: 10.1007/s00432-013-1382-8. Epub 2013 Feb 8. PMID 23392859
- BACKGROUNDFujii R, Hanamura T, Suzuki T, Gohno T, Shibahara Y, Niwa T, Yamaguchi Y, Ohnuki K, Kakugawa Y, Hirakawa H, Ishida T, Sasano H, Ohuchi N, Hayashi S. Increased androgen receptor activity and cell proliferation in aromatase inhibitor-resistant breast carcinoma. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt B:513-22. doi: 10.1016/j.jsbmb.2014.08.019. Epub 2014 Aug 29. PMID 25178713
- BACKGROUNDCiupek A, Rechoum Y, Gu G, Gelsomino L, Beyer AR, Brusco L, Covington KR, Tsimelzon A, Fuqua SA. Androgen receptor promotes tamoxifen agonist activity by activation of EGFR in ERalpha-positive breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):225-37. doi: 10.1007/s10549-015-3609-7. Epub 2015 Oct 20.