Abstract PD5-04: NSABP FB-7: A phase II randomized trial evaluating neoadjuvant therapy with weekly paclitaxel (P) plus neratinib (N) or trastuzumab (T) or neratinib and trastuzumab (N+T) followed by doxorubicin and cyclophosphamide (AC) with postoperative T in women with locally advanced HER2-positive breast cancer
Notice bibliographique
Résumé
Abstract Background: Trastuzumab (T), the first anti-HER-2-directed therapy, dramatically changed the natural history of operable HER-2 positive breast cancer. A subsequent improvement occurred when pertuzumab was added to a T/docetaxel regimen in NeoSphere, a phase II randomized neoadjuvant trial, in which the pathologic complete response rate (pCR) in breast and nodes was increased from 21.5% to 39.3%, leading to accelerated approval of this combination by the FDA. Another dual anti-HER trial, NeoALTTO, which combined lapatinib with T, resulted in pCR (breast and nodes) increase from 27.6% to 46.8%. Neratinib (N) + paclitaxel (P) followed by AC was tested in the neoadjuvant I-SPY 2 trial resulting in pCR of 55% for hormone-negative, HER2-positive breast cancer. A 300-patient phase III trial of N or T with standard chemotherapy is planned. In the FB-7 phase II trial in HER2-positive patients (pts) with locally advanced disease, pts were randomly assigned to N or T or the combination (N+T) with weekly P followed by standard AC. Arm 3 of this trial, N+T+P, was based on the phase Ib results from NSABP FB-8, a study in heavily pretreated HER2-positive metastatic breast cancer pts, which demonstrated an overall response rate of 38% and clinical benefit rate of 52%. Methods: NSABP FB-7 opened in October 2010 as a two-arm trial (Arm 1, N+P→AC and Arm 2, T+P→AC). After accrual of 30 pts, accrual was suspended in December 2011 as NSABP FB-8, a phase Ib trial of neratinib, trastuzumab, and paclitaxel (N+T+P), was conducted and a recommended phase II dose for the combination of N+T+P was determined. NSABP FB-7 reopened in September 2012 adding Arm 3 (N+T+P→AC). 141 pts enrolled in this trial between October 2010 and November 2014. Three withdrew consent before treatment and were replaced. A total of 126 US, Canadian, and European pts were randomized to Arm 1 (N+P→AC), Arm 2 (T+P→AC) or Arm 3 (N+T+P→AC). 12 additional pts from the US were treated on Arm 3 as nonrandomized (NR) pts. These NR pts are included for toxicity but not for efficacy. Eligibility criteria included women >18 years of age, ECOG PS 0-1, stage IIB-IIIC invasive breast cancer, HER2-positivity by IHC 3+, FISH, or CISH as determined by local laboratories, hormone receptor positive or negative, LVEF >50%, and adequate laboratory parameters. The primary endpoint is pCR in breast and nodes. Conclusions: The last patient enrolled on this trial in November 2014. Datalock for the primary endpoint will occur on or before September 1, 2015. Pathologic complete response data and toxicity will be reported on the entire cohort of pts. Biomarkers will be analyzed on a subset of pts. Support: Puma Biotechnology, Inc. Citation Format: Jacobs SA, Robidoux A, Garcia JMP, Abraham J, La Verde N, Orcutt JM, Cazzaniga ME, Calvo L, Aguirre E, Buyse M, Pogue-Geile KL, Srinivasan A, Song N, Balousek AD, Wolmark N. NSABP FB-7: A phase II randomized trial evaluating neoadjuvant therapy with weekly paclitaxel (P) plus neratinib (N) or trastuzumab (T) or neratinib and trastuzumab (N+T) followed by doxorubicin and cyclophosphamide (AC) with postoperative T in women with locally advanced HER2-positive breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr PD5-04.
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 | 0,005 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,003 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».