Summary
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Breast Cancer: 2 are currently recruiting; 3 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00590213). It plans or enrolled 125 participants. Registration activity spans 2003 to 2024. The literature layer holds 3 publications for this pair: 3 clinical trial publications. Publication years run from 2013 to 2021. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Breast Cancer ranks 1462 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression documented but rare (<0.5%); 5-year survival stage I: ~99%; stage IV: ~28% overall, improving with modern therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 54.5 (trials 28.5, literature 6.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 3 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 3 (3 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00590213 | Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX 2003 | completed | Phase 4 | 125 |
| NCT03055312 | Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer 2016 | terminated | Phase 3 | 36 |
| NCT03650894 | Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients 2019 | active, not recruiting | Phase 2 | 30 |
| NCT06727357 | Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP 2019 | active, not recruiting | Phase 2 | 38 |
| NCT00468715 | Bicalutamide in Treating Patients With Metastatic Breast Cancer 2007 | completed | Phase 2 | 28 |
| NCT06365788 | Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer 2024 | recruiting | Phase 2 | 53 |
| NCT02605486 | Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) 2015 | active, not recruiting | PHASE1, PHASE2 | 46 |
| NCT05095207 | Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer 2021 | recruiting | PHASE1, PHASE2 | 42 |
Published literature
- Clinical trial publication Serial [(18)F]-FDHT-PET to predict bicalutamide efficacy in patients with androgen receptor positive metastatic breast cancerBoers J, Venema CM, de Vries EFJ et al. · European journal of cancer (Oxford, England : 1990) · 2021 · PMID 33341447
- Clinical trial publication Bicalutamide plus Aromatase Inhibitor in Patients with Estrogen Receptor-Positive/Androgen Receptor-Positive Advanced Breast CancerLu Q, Xia W, Lee K et al. · The oncologist · 2020 · PMID 31434793
- Clinical trial publication Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast CancerGucalp A, Tolaney S, Isakoff SJ et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2013 · PMID 23965901
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bicalutamide approved for Breast Cancer?
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Bicalutamide in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Breast Cancer: 2 are currently recruiting; 3 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00590213). It plans or enrolled 125 participants. Registration activity spans 2003 to 2024.
What does the evidence show for Bicalutamide in Breast Cancer?
Bicalutamide has 2 completed trials and 3 linked publications for Breast Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.