Breast Cancer Foundation NZ
AMEERA-3
Advanced Breast Cancer clinical trials for ER+
This study will determine whether SAR439859 per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer.
This study will determine whether SAR439859 per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer.
Who is it for?
You may be eligible for this study if you meet the below criteria:
- 18 years or older.
- Histological or cytological diagnosis of adenocarcinoma of the breast.
- Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
- ER positive status.
- HER2 negative status.
- For patients with tumor accessible for paired biopsy at study entry: baseline samples, formalin fixed paraffin embedded (FFPE) archived biopsy samples (within three months prior initiation of study treatment) can be used, but preferably fresh biopsies from primary tumor or recurrence or metastasis, will be collected.
- Participants must have received no more than one prior chemotherapeutic or one targeted therapy regimen for advanced/metastatic disease.
- Participants must have progressed after at least six months of a continuous prior endocrine therapy for advanced breast cancer.
- Male or female.
Study details
Participants will receive either endocrine monotherapy as per physician choice or daily SAR439859 dose administered orally. The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to four weeks (28 days), a treatment period of at least one cycle (28 days of study treatment), and an end of treatment (EOT) visit at least 30 days (or until the participant receive another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, death or upon participant's request.
Australia
If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz
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