Clinical trial · Interventional
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment
A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status
NCT01596530CI-TRIAL-00008678CHIVEterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All AstraZeneca sponsored clinical trials of AZD8931 have been halted
Summary
Brief summary (as posted)
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug-AZD8931 | Drug | — | UNRESOLVED |
| Drug-Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AZD8931
- description
- AZD8931
- interventionNames
- Drug: Drug-AZD8931
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Drug-Placebo
Primary outcomes (1)
- measure
- Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment
- timeFrame
- Day 7 - Day 14
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged 18 or older Early stage breast cancer and planned surgery * Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines * World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing. Exclusion Criteria: * Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class; * Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease * Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6
References
Publications (0)
Data not yet available
No reference posted for this study.