DiEtary Mimicry by Glucocorticoid Modulation Evaluation in ER+ Metastatic Breast Cancer Treatment: Efficacy and Response (DEMETER Trial)

Sponsor
The Netherlands Cancer Institute
Study ID
NCT07786051
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone (Oral) — DRUG
    Commercially available Dexamethasone in tablet form 1.5mg or 4mg

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Nov 1, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose 1 Dexamethasone + prior ET
    Dose 1 = Dexamethasone 3mg once daily, 1 week on, 3 weeks off schedule
  • Experimental: Part 2: Dose 2 Dexamethasone + prior ET
    Dose 2 = Dexamethasone either 1.5mg or 4mg once daily, 1 week on, 3 weeks off schedule. Depending on the results of Part 1.

Primary Outcome Measure

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. [ Time Frame: At the 16th week tumour evaluation. ]

Central Contacts

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