Clinical trial · Interventional
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow and low enrollment
Summary
Brief summary (as posted)
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screening prior to entry.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dovitinib | Drug | Dovitinib | ALIAS |
| Dovitinib Placebo | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fulvestrant + Dovitinib active
- description
- Fulvestrant in combination with the study drug Dovitinib.
- interventionNames
- Drug: Dovitinib
- Drug: Fulvestrant
- type
- PLACEBO_COMPARATOR
- label
- Fulvestrant + Dovitinib placebo
- description
- Fulvestrant in combination with a placebo matching Dovitinib.
- interventionNames
- Drug: Fulvestrant
- Drug: Dovitinib Placebo
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Based on Local Investigator Assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer * Progression on or after endocrine treatment * Measureable disease as per RECIST * ECOG 0, 1 or 2 Exclusion Criteria: * Evidence of CNS or leptomeningeal metastases * Previous treatment with fulvestrant * Previous chemotherapy for locally advanced or metastatic breast cancer * Cirrhosis or chronic active/persistent hepatitis Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDMusolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, Andre F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2- breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8. PMID 28183331