Clinical trial · Interventional
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
NCT01597388CI-TRIAL-00103960completedPhase 1Results postedClinicalTrials.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)
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
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 |
|---|---|---|---|
| Advanced Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD2014 | Drug | Vistusertib | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD2014 with Fulvestrant
- description
- AZD2014 with Fulvestrant
- interventionNames
- Drug: AZD2014
- Drug: Fulvestrant
Primary outcomes (24)
- measure
- Adverse Events
- timeFrame
- Up to 12 Months
- measure
- Adverse Events Leading to Dose Reduction of AZD2014
- timeFrame
- Up to 28 Days
- measure
- Clinically Important Changes in Haematology Parameters
- timeFrame
- Up to 12 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis * Aged at least 18 * At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment * Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients must have evidence of non-child-bearing potential. Exclusion Criteria: * Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites) * Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study. * Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions. * Patients with diabetes type 1 or uncontrolled type II (HbA1c \> 8% assessed locally)
References
Publications (0)
Data not yet available
No reference posted for this study.