Clinical trial · Interventional
The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy
- 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 compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Exemestane
- interventionNames
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
- 2
- description
- Fulvestrant
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Time to disease progression (TTP)
- timeFrame
- after 580 Progression events accrued
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 32 Years
- Maximum age
- 91 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy confirmation of Breast Cancer * Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor * Postmenopausal women defined as a women who has stopped having menstrual periods * Evidence of hormone sensitivity * Written informed consent to participate in the trial Exclusion Criteria: * Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane) * Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor * Treatment with an investigational or non-approved drug within one month * An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures * A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)
References
Publications (1)
- DERIVEDArizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24. PMID 39046616