Search Results - "Paux, Gautier"

Utilization of treatment effect on a surrogate endpoint for planning a study to evaluate treatment effect on a final endpoint by Quan, Hui, Xu, Zhixing, Luo, Junxiang, Paux, Gautier, Cho, Meehyung, Chen, Xun

“…To design a phase III study with a final endpoint and calculate the required sample size for the desired probability of success, we need a good estimate of the…”
Get full text

AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer by Bardia, Aditya, Chandarlapaty, Sarat, Linden, Hannah M., Ulaner, Gary A., Gosselin, Alice, Cartot-Cotton, Sylvaine, Cohen, Patrick, Doroumian, Séverine, Paux, Gautier, Celanovic, Marina, Pelekanou, Vasiliki, Ming, Jeffrey E., Ternès, Nils, Bouaboula, Monsif, Lee, Joon Sang, Bauchet, Anne-Laure, Campone, Mario

“…AMEERA-1 is a Phase 1/2 open-label single-arm study evaluating once-daily (QD) amcenestrant, an orally bioavailable selective estrogen receptor (ER) degrader,…”
Get full text

Penalty-based approaches to evaluating multiplicity adjustments in clinical trials: Advanced multiplicity problems by Paux, Gautier, Dmitrienko, Alex

“…Given the importance of addressing multiplicity issues in confirmatory clinical trials, several recent publications focused on the general goal of identifying…”
Get full text

Penalty-based approaches to evaluating multiplicity adjustments in clinical trials: Traditional multiplicity problems by Paux, Gautier, Dmitrienko, Alex

“…Given the importance of addressing multiplicity issues in confirmatory clinical trials, several recent publications focused on the general goal of identifying…”
Get full text

AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer by Campone, Mario, Bidard, François-Clément, Neven, Patrick, Wang, Lei, Ling, Bin, Dong, Yvonne, Paux, Gautier, Herold, Christina, De Giorgi, Ugo

“…Background Window-of-opportunity (WOO) studies provide insights into the clinical activity of new drugs in breast cancer. Methods AMEERA-4 (NCT04191382) was a…”
Get full text

Adjuvant endocrine therapy uptake, toxicity, quality of life, and prediction of early discontinuation by Balazard, Félix, Bertaut, Aurélie, Bordet, Élise, Mulard, Stéphane, Blanc, Julie, Briot, Nathalie, Paux, Gautier, Dhaini Merimeche, Asma, Rigal, Olivier, Coutant, Charles, Fournier, Marion, Jouannaud, Christelle, Soulie, Patrick, Lerebours, Florence, Cottu, Paul-Henri, Tredan, Olivier, Vanlemmens, Laurence, Levy, Christelle, Mouret-Reynier, Marie-Ange, Campone, Mario, Brady, Keri J S, Sasane, Medha, Rice, Megan, Coulouvrat, Catherine, Martin, Anne-Laure, Jacquet, Alexandra, Vaz-Luis, Ines, Herold, Christina, Pistilli, Barbara

“…Abstract Background Many patients receiving adjuvant endocrine therapy (ET) for breast cancer experience side effects and reduced quality of life (QoL) and…”
Get full text

Applications of Bayesian analysis to proof‐of‐concept trial planning and decision making by Quan, Hui, Chen, Xun, Lan, Yu, Luo, Xiaodong, Kubiak, Rene, Bonnet, Nicolas, Paux, Gautier

“…Decision making is a critical component of a new drug development process. Based on results from an early clinical trial such as a proof of concept trial, the…”
Get full text

Use of Seamless Study Designs in Oncology Clinical Development- A Survey Conducted by IDSWG Oncology Sub-team by Dong, Yingwen, Paux, Gautier, Broglio, Kristine, Cooner, Freda, Gao, Guozhi, He, Wei, Gao, Lei, Xue, Xiaoqiang, He, Philip

“…Seamless study designs have the potential to accelerate clinical development. The use of innovative seamless designs has been increasing in the oncology area;…”
Get more information

Development of gatekeeping strategies in confirmatory clinical trials by Dmitrienko, Alex, Millen, Brian A., Brechenmacher, Thomas, Paux, Gautier

“…This paper discusses multiplicity issues arising in confirmatory clinical trials with hierarchically ordered multiple objectives. In order to protect the…”
Get full text

Reply to Y. Yoshitomi et al by Tolaney, Sara M, De Kermadec, Elisabeth, Cohen, Patrick, Paux, Gautier, Wang, Lei, Im, Seock-Ah

Get full text

AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer by Tolaney, Sara M, Chan, Arlene, Petrakova, Katarina, Delaloge, Suzette, Campone, Mario, Iwata, Hiroji, Peddi, Parvin F, Kaufman, Peter A, De Kermadec, Elisabeth, Liu, Qianying, Cohen, Patrick, Paux, Gautier, Wang, Lei, Ternès, Nils, Boitier, Eric, Im, Seock-Ah

“…Amcenestrant (oral selective estrogen receptor degrader) demonstrated promising safety and efficacy in earlier clinical studies for endocrine-resistant,…”
Get full text

Implementation of adaptive methods in early‐phase clinical trials by Petroni, Gina R., Wages, Nolan A., Paux, Gautier, Dubois, Frédéric

“…There has been constant development of novel statistical methods in the design of early‐phase clinical trials since the introduction of model‐based designs,…”
Get full text

Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5 by Cortés, Javier, Hurvitz, Sara A, O'Shaughnessy, Joyce, Delaloge, Suzette, Iwata, Hiroji, Rugo, Hope S, Neven, Patrick, Kanagavel, Dheepak, Cohen, Patrick, Paux, Gautier, Cartot-Cotton, Sylvaine, Stefanova-Urena, Maya, Deyme, Laure, Aouni, Jihane, Sebastien, Bernard, Bardia, Aditya

“…AMEERA-5 investigated amcenestrant (oral selective estrogen receptor [ER] degrader) plus palbociclib versus letrozole plus palbociclib as first-line treatment…”
Get full text

Phase III (IMROZ) study design: Isatuximab plus bortezomib (V), lenalidomide (R), and dexamethasone (d) vs VRd in transplant-ineligible patients (pts) with newly diagnosed multiple myeloma (NDMM) by Orlowski, Robert Z., Goldschmidt, Hartmut, Cavo, Michele, Martin, Thomas G., Paux, Gautier, Oprea, Corina, Facon, Thierry

“…Abstract only…”
Get full text

Abstract P1-17-11: Updated data from AMEERA-1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), combined with palbociclib in postmenopausal women with ER+/HER2- advanced breast cancer by Chandarlapaty, Sarat, Linden, Hannah M, Neven, Patrick, Petrakova, Katarina, Bardia, Aditya, Kabos, Peter, Braga, Sofia, Boni, Valentina, Gosselin, Alice, Celanovic, Marina, Cohen, Patrick, Paux, Gautier, Pelekanou, Vasiliki, Ternès, Nils, Lee, Joon Sang, Campone, Mario

“…Background: In Arm 2 of the ongoing AMEERA-1 trial (NCT03284957), amcenestrant, an optimized oral SERD combined with the CDK4/6 inhibitor (CDK4/6i) palbociclib…”
Get full text

AMEERA-1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib (palbo) in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) by Chandarlapaty, Sarat, Linden, Hannah M., Neven, Patrick, Petrakova, Katarina, Bardia, Aditya, Kabos, Peter, Braga, Sofia A. D. S., Boni, Valentina, Gosselin, Alice, Cartot-Cotton, Sylvaine, Doroumian, Séverine, Celanovic, Marina, Cohen, Patrick, Paux, Gautier, Campone, Mario

“…Abstract only 1058 Background: AMEERA-1 (NCT03284957) investigates amcenestrant, an oral SERD, as monotherapy and combined with targeted therapies in ER+/HER2–…”
Get full text

Adjuvant study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer (EBC), who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6) by Meyskens, Thomas, Metzger, Otto, Poncet, Coralie, Goulioti, Theodora, Xenophontos, Eleni, Carey, Lisa A., Wang, Lei, Rossi, Giovanna, Gilham, Leslie, De Swert, Heidi, Casas-Martin, Jose, Attieh, Elham, Arahmani, Amal, De Meulemeester, Laura, Partridge, Ann H., Herold, Christina Isabella, Paux, Gautier, Dueck, Amylou C., Brain, Etienne, Cameron, David A.

“…TPS607 Background: There are currently limited treatment options for patients with HR+ EBC who have discontinued adjuvant treatment with aromatase inhibitors…”
Get full text

Abstract P1-13-08: Patterns of adjuvant endocrine therapy, discontinuations, toxicities and quality of life: Development of a model for early discontinuation using the CANTO cohort by Balazard, Felix, Bertaut, Aurélie, Bordet, Élise, Mulard, Stéphane, Blanc, Julie, Briot, Nathalie, Paux, Gautier, Merimeche, Asma Dhaini, Rigal, Olivier, Coutant, Charles, Fournier, Marion, Jouannaud, Christelle, Soulie, Patrick, Lerebours, Florence, Cottu, Paul-Henri, Tredan, Olivier, Vanlemmens, Laurence, Levy, Christelle, Mouret-Reynier, Marie-Ange, Campone, Mario, Brady, Keri J. S., Sasane, Medha, Rice, Megan, Coulouvrat, Catherine, Martin, Anne-Laure, Jacquet, Alexandra, Vaz-Luis, Ines, Herold, Christina, Pistilli, Barbara

“…Long-term adherence to adjuvant endocrine therapy (ET, tamoxifen and aromatase inhibitors) is paramount for patients with early-stage breast cancer. Adherence…”
Get full text

Tradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs by Dmitrienko, Alex, Paux, Gautier, Pulkstenis, Erik, Zhang, Jianliang

“…The article discusses clinical trial optimization problems in the context of mid- to late-stage drug development. Using the Clinical Scenario Evaluation…”
Get full text

Abstract OT1-04-01: AMEERA-6: Phase 3 Study of Adjuvant Amcenestrant Versus Tamoxifen for Patients With Hormone Receptor-Positive Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity by Metzger, Otto, Herold, Christina, Poncet, Coralie, De Swert, Heidi, Casas-Martin, Jose, Partridge, Ann, Guita, Samia, Carey, Lisa, Schumacher, Eva, Goulioti, Theodora, Meyskens, Thomas, Gannon, Joseph, Benlhassan, Khadija, Rossi, Giovanna, Xenophontos, Eleni, Arahmani, Amal, Dueck, Amylou C., Paux, Gautier, Brain, Etienne, Cameron, David A.

“…Background: About 30% of patients (pts) with hormone receptor (HR)-positive early breast cancer (EBC) on adjuvant aromatase inhibitor (AI) therapy discontinue…”
Get full text