This is a single centre, open label, phase II clinical study consisting of two parts, each consisting of a different dose of the same intervention to investigate the efficacy of dexamethasone as an adjunct to endocrine therapy in the treatment of ER+ HER2- metastatic breast cancer after progression on the same endocrine therapy.
Have provided written informed consent and are willing to comply to study procedures and treatment plan.
Documentation of histologically confirmed diagnosis of oestrogen receptor (ER) expression >10% breast cancer based on local laboratory results. Tumour must be HER2 negative as defined by American Society of Clinical Oncology - College of American Pathologists (ASCOCAP) guidelines. If HER2 status is unavailable, then testing must be performed/repeated.
Have relapsed/refractory to treatment with aromatase inhibitors or Fulvestrant as monotherapy or in combination with CDK4/6 inhibitors in the 1st or 2nd line in metastatic setting. Prior treatment discontinuation must not be > 8 weeks ago.
Pre-menopausal women are required to have ovarian function suppression by means of bilateral oophorectomy or continued LHRH/GnRH agonists treatment.
Primary endocrine resistance: Progressed on endocrine therapy within 6 months of initiating treatment in the 1st line for advanced or mBC, or relapsed within first 2 years of endocrine therapy in the adjuvant setting.
Metastases such as massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and >50% liver involvement which have risk of life-threatening complications in the short term.
Known Central Nervous System (CNS) metastases.
Current use of corticosteroids including local administration such as intranasal, intraocular, intra-articular, inhaled or topical application, and/or having ongoing conditions requiring long-term use of corticosteroids.
Sequential
Dexamethasone (Oral)
DrugCommercially available Dexamethasone in tablet form 1.5mg or 4mg
Clinical Benefit Rate, which is defined as the proportion of participants having stable disease, partial response or complete response at the 16th week tumour evaluation.
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The Netherlands Cancer Institute
Lead sponsor
Oncode Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
