Clinical trial · Interventional
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination With Anastrozole, Compared to Anastrozole Alone, in Post Menopausal Women With Hormone Receptor Positive, Endocrine Therapy Naive, Locally Advanced or Metastatic Breast Cancer (MINT).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility
Summary
Brief summary (as posted)
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
Conditions
Conditions (3)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| AZD8931 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- AZD8931 40mg (bd) plus anastrozole 1mg (od)
- interventionNames
- Drug: AZD8931
- Drug: anastrozole
- type
- EXPERIMENTAL
- label
- 2
- description
- AZD8931 20mg (bd) plus anastrozole 1mg (od)
- interventionNames
- Drug: AZD8931
- Drug: anastrozole
- type
- PLACEBO_COMPARATOR
- label
- 3
- description
- Placebo (bd) plus anastrozole 1mg (od)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients that have locally advanced or metastatic breast cancer. Lesions should not be amenable to surgery or radiation of curative intent * Hormone therapy-naive * Estimated life expectancy of more than 12 weeks Exclusion Criteria: * Last dose of prior anti-cancer therapy received within 14 days (or longer if required) * Any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug. * Currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose \<7 days prior to randomisation)
References
Publications (1)
- DERIVEDJohnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21. PMID 27654971