Studieoverzicht - 2020-02 AMEERA-5
| Number | 2020-02 AMEERA-5 | ||||
| Nickname | AMEERA-5 | ||||
| Status | Active, not recruiting | Date: 16-08-2022 | |||
| Inclusion closed | 03-12-2021 | ||||
| Other study number(s) | EFC15935 | ||||
| Participating parties/groups | Sanofi | ||||
| Full title | A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥ 18 years | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Advanced/metastatic | ||||
| Subindication | HER2- HR+ | ||||
| Target sample size | 1066 (global) | ||||
| Actual accrual | 1068 (NL:4) | Date: 09-12-2021 | |||
| Estimated study completion date | 01-05-2027 | ||||
| CCMO approval | Yes | Date: 02-09-2020 | Nr: | ||
| EudraCT nr. | 2020-001824-33 | ||||
| Trial Register | NCT04478266 | ||||
| METC approval | Yes | Date: 10-11-2020 | METC: | Nr: 20-073 | |
| Amendments | Date: | ||||
| KWF-CKS approval | Not applicable | Date: | Nr: | ||
| News item | |||||
| Website | https://clinicaltrials.gov/ct2/show/NCT04478266 , voor patienten: https://www.kanker.nl/trials/1236-ameera-5--studie-borstkanker | ||||
| Sponsor | Sanofi | ||||
| Principal Investigator(s) | ||||
| Study manager | ||||
| Central datamanagement and randomization | Sanofi |
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| Monitoring | Sanofi | |||
| Local datamanagement | ||||
| Funding | Sanofi | |||
| Extra | study status since 16-dec-2021: Active, not recruiting | |||
A Randomized, Multicenter, Double-blind Phase 3 Study
To determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Progression-free survival. Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.
The most important inclusion criteria are:
- Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
- Confirmed diagnosis of ER+/HER2- breast cancer
- No prior systemic treatment for loco-regional recurrent or metastatic disease
- Measurable or non-measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants should be willing to provide tumor tissue
The most important exclusion criteria are:
- Known brain metastases that are untreated, symptomatic or require treatment to control symptoms
- Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
- Inadequate organ and marrow function
- Disease recurrence while on, or within 12 months of completion of (neo)adjuvant aromatase inhibitor-containing therapy
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
- Male participants who disagree to follow contraception
- Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
- Participants with significant concomitant illness
Deelnemende centra:
Maastricht UMC+
Spaarne Gasthuis Hoofddorp
Reinier de Graaf Gasthuis
Rijnstate Arnhem
Amphia ziekenhuis, Breda
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