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The combination of Elacestrant and exemestane for patients with pretreated metastatic breast cancer expressing hormone receptors and non-expressing HER2, with lesions which uptake [18F]FES-avid (COMBINE): a proof-of-concept phase 2 clinical trial
EU CTIS ID: 2024-519792-25-00
What this study is testing
To assess the activity of elacestrant plus exemestane
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years old
- Histologically - or cytologically-proven diagnosis of HR+ (Estrogen Receptor: ≥10%)/HER2- carcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy
- Appropriate candidates for endocrine therapy (no visceral crisis, highly symptomatic disease or rapidly progressing disease)
- Measurable disease per RECIST or bone only disease with evaluable lesions
- ≥50% of measurable lesions defined as avid (SUVmax≥1.5) at 18F-FES-PET/CT
- Progressed on prior treatment with a CDK4/6 inhibitor in combination with anastrozole or letrozole (+ LHRH agonist for male or premenopausal female patients), in first line setting for metastatic disease, for at least 12 months and there must have been evidence of disease control (at least stable disease per RECIST v.1.1)
You likely can't join if
- Prior treatment with fulvestrant, elacestrant or investigational SERD or ER antagonist in metastatic or early disease
- Prior treatment with tamoxifen or SERD alone or combined with CDK4/6i in the metastatic setting
- Bisphosphonates or RANKL inhibitors initiated or dose changed < 3 months prior to first dose of study drug
- Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug
- Presence of symptomatic metastatic visceral disease or meningeal disease
- Pregnancy at the time of the study entry
See the full eligibility criteria
- At least 18 years old
- Histologically - or cytologically-proven diagnosis of HR+ (Estrogen Receptor: ≥10%)/HER2- carcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy
- Appropriate candidates for endocrine therapy (no visceral crisis, highly symptomatic disease or rapidly progressing disease)
- Measurable disease per RECIST or bone only disease with evaluable lesions
- ≥50% of measurable lesions defined as avid (SUVmax≥1.5) at 18F-FES-PET/CT
- Progressed on prior treatment with a CDK4/6 inhibitor in combination with anastrozole or letrozole (+ LHRH agonist for male or premenopausal female patients), in first line setting for metastatic disease, for at least 12 months and there must have been evidence of disease control (at least stable disease per RECIST v.1.1)
- ECOG performance status 0 or 1
- Adequate organ function
- Prior treatment with fulvestrant, elacestrant or investigational SERD or ER antagonist in metastatic or early disease
- Prior treatment with tamoxifen or SERD alone or combined with CDK4/6i in the metastatic setting
- Bisphosphonates or RANKL inhibitors initiated or dose changed < 3 months prior to first dose of study drug
- Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug
- Presence of symptomatic metastatic visceral disease or meningeal disease
- Pregnancy at the time of the study entry
- Diagnosis of inflammatory breast cancer and chest wall disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.