Abstract P5-19-09: Preliminary results from a phase 2 single-arm study of enzalutamide, an androgen receptor (AR) inhibitor, in advanced AR+ triple-negative breast cancer (TNBC)
Notice bibliographique
Résumé
Abstract Background AR expression has been observed in 10-30% of patients with TNBC. AR+ TNBC cell lines demonstrated enhanced growth in response to androgen stimulation that is inhibited by enzalutamide (ENZA), a potent oral inhibitor of AR signaling. AR+ TNBC may represent a subtype driven by AR signaling that may respond to ENZA. Methods MDV3100-11 is an open-label, Simon 2-stage study designed to evaluate single agent ENZA (160 mg PO daily) in women with advanced AR+ TNBC (NCT01889238). Patients must have measurable or bone-only non-measurable disease. Baseline CNS imaging is required to exclude patients with CNS metastases. Patients with a seizure history are excluded. "AR+" for eligibility is defined as any nuclear AR expression by immunohistochemistry (IHC); TNBC is defined as estrogen receptor and progesterone receptor <1% by IHC and human epidermal growth factor receptor 2 IHC 0 or 1+ or non-amplified for IHC 2+. The primary endpoint is clinical benefit rate (CBR), defined as complete or partial response (CR or PR) or stable disease ≥16 weeks as assessed by the Investigator according to RECIST 1.1 based on the evaluable patient population. Additional endpoints include CBR at 24 weeks, response rates, safety, and tolerability. An evaluable patient is defined as having ≥10% AR staining and a postbaseline tumor assessment for response by RECIST 1.1. The study enrolls a total of 62 evaluable patients if the primary endpoint is achieved by ≥3 patients among the first 26 evaluable patients in Stage 1. Results Preliminary results are available for a subset of the first 26 evaluable patients enrolled; 14 patients have discontinued study due to progressive disease at week 16 or earlier. Eight patients have achieved the primary endpoint; 4 additional active patients have not had their week 16 assessment but achieved stable disease or better at 8 weeks. The current CBR rate is therefore 31%, and could go as high as 46% if all 4 additional patients show at least stable disease or better at their week 16 assessment. Of the 8, 2 discontinued (1 each at weeks 21 and 37), 2 had objective responses (1 PR and 1 CR), and 6 have been on study for ≥24 weeks without disease progression. The toxicity profile of ENZA is so far consistent with other hormone therapies. Full safety and efficacy data on the first 26 evaluable patients enrolled in Stage 1 will be available for inclusion at the time of the late breaking abstract. Conclusion Currently, there is no targeted therapy approved for patients with TNBC. Cytotoxics remain the standard of care in this setting. Preliminary activity and tolerability observed with ENZA are encouraging and raise the possibility that some patients with TNBC may benefit from targeted inhibition of AR signaling, thereby avoiding or delaying cytotoxic regimens. Placeholder abstract: This is a placeholder abstract; we are expecting results from the first subset of 26 evaluable patients to be ready by September 2014. Citation Format: Tiffany A Traina, Joyce O'Shaughnessy, Rita Nanda, Lee Schwartzberg, Vandana Abramson, Javier Cortes, Amy Peterson, Iulia Cristina Tudor, Martha Blaney, Joyce L Steinberg, Catherine Kelly, Maureen Trudeau, Ahmad Awada, Eric Winer, Clifford Hudis, Peter Schmid, Denise A Yardley. Preliminary results from a phase 2 single-arm study of enzalutamide, an androgen receptor (AR) inhibitor, in advanced AR+ triple-negative breast cancer (TNBC) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-19-09.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».