Phase III study of GDC-0077 or placebo (pbo) with palbociclib (P) plus fulvestrant (F) in patients with PIK3CA-mutant/hormone receptor-positive/HER2-negative locally advanced or metastatic breast cancer (HR+/HER2-LA/MBC)

被引:0
|
作者
Turner, Nicolas [1 ,2 ]
Jhaveri, Komal [3 ]
Kalinsky, Kevin [4 ]
Loibl, Sibylle [5 ]
Loi, Sherene [6 ]
Im, Seock-Ah [7 ]
Saura, Cristina [8 ]
Schmid, Peter [9 ]
Schutzman, Jennifer L. [10 ]
Stout, Thomas J. [11 ]
Lei, Guiyuan [12 ]
Hutchinson, Katherine E. [13 ]
Thanopoulou, Eirini [14 ]
Juric, Dejan [15 ]
机构
[1] Royal Marsden Hosp, London, England
[2] Inst Canc Res, London, England
[3] Mem Sloan Kettering Canc Ctr, Dept Med, Mem Hosp, 1275 York Ave, New York, NY 10021 USA
[4] Columbia Univ, Dept Med, Irving Med Ctr, New York, NY USA
[5] GBG Forschungs GmbH, Med & Res, Neu Isenburg, Germany
[6] Peter MacCallum Canc Ctr, Div Res, Melbourne, Vic, Australia
[7] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea
[8] Vall dHebron Inst Oncol VHIO, Vall dHebron Univ Hosp, Med Oncol Dept, Barcelona, Spain
[9] Canc Res UK Barts Ctr, Ctr Expt Canc Med, London, England
[10] Genentech Inc, gRED Genentech Res & Early Dev, San Francisco, CA 94080 USA
[11] Genentech Inc, Oncol, Prod Dev, San Francisco, CA 94080 USA
[12] Roche Prod Ltd, Biometr, Welwyn Garden City, Herts, England
[13] Genentech Inc, Oncol Biomarkers, San Francisco, CA 94080 USA
[14] Genentech Inc, Prod Dev, Oncol, Welwyn Garden City, Herts, England
[15] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA
关键词
D O I
暂无
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
OT-36-01
引用
收藏
页数:1
相关论文
共 50 条
  • [1] Phase III study of GDC-0077 or placebo (pbo) with palbociclib (P) plus fulvestrant (F) in patients (pts) with PIK3CA-mutant/hormone receptor-positive/HER2-negative locally advanced or metastatic breast cancer (HR+/HER2-LA/MBC)
    Turner, N.
    Jhaveri, K.
    Kalinsky, K.
    Loibl, S.
    Loi, S.
    Im, S-A.
    Saura, C.
    Schmid, P.
    Schutzman, J. L.
    Stout, T.
    Lei, G.
    Hutchinson, K. E.
    Thanopoulou, E.
    Juric, D.
    [J]. ANNALS OF ONCOLOGY, 2020, 31 : S391 - S392
  • [2] A phase I/Ib study evaluating GDC-0077+palbociclib (palbo) plus fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2-mBC)
    Bedard, Philippe L.
    Jhaveri, Komal
    Cervantes, Andres
    Gambardella, Valentina
    Hamilton, Erika
    Italiano, Antoine
    Kalinsky, Kevin
    Krop, Ian E.
    Oliveira, Mafalda
    Saura, Cristina
    Schmid, Peter
    Turner, Nicolas
    Varga, Andrea
    Hutchinson, Katherine E.
    Lei, Guiyuan
    Royer-Joo, Stephanie
    Thomas, Piia
    Schutzman, Jennifer L.
    Juric, Dejan
    [J]. CANCER RESEARCH, 2021, 81 (04)
  • [3] A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer
    Juric, Dejan
    Bedard, Phillippe L.
    Cervantes, Andres
    Gambardella, Valentina
    Oliveira, Mafalda
    Saura, Cristina
    Kalinsky, Kevin M.
    Hamilton, Erika
    Italiano, Antoine
    Krop, Ian E.
    Schmid, Peter
    Turner, Nicholas C.
    Varga, Andrea
    Royer-Joo, Stephanie
    Hutchinson, Katherine E.
    Schutzman, Jennifer L.
    Jhaveri, Komal L.
    [J]. CANCER RESEARCH, 2022, 82 (04)
  • [4] Targeted safety events from a phase I/Ib study evaluating GDC-0077 alone and in combination with endocrine therapy (ET) ± palbociclib (palbo) in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2-mBC)
    Olivera, Mafalda
    Jhaveri, Komal
    Juric, Dejan
    Bedard, Philippe L.
    Cervantes, Andres
    Gambardella, Valentina
    Hamilton, Erika
    Italiano, Antoine
    Kalinsky, Kevin
    Krop, Ian E.
    Schmid, Peter
    Turner, Nicolas
    Varga, Andrea
    Lei, Guiyuan
    Royer-Joo, Stephanie
    Thomas, Piia
    Schutzman, Jennifer L.
    Saura, Cristina
    [J]. CANCER RESEARCH, 2021, 81 (04)
  • [5] Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial
    Dent, S.
    Cortes, J.
    Im, Y-H
    Dieras, V
    Harbeck, N.
    Krop, I. E.
    Wilson, T. R.
    Cui, N.
    Schimmoller, F.
    Hsu, J. Y.
    He, J.
    De Laurentiis, M.
    Sousa, S.
    Drullinsky, P.
    Jacot, W.
    [J]. ANNALS OF ONCOLOGY, 2021, 32 (02) : 197 - 207
  • [6] Preliminary correlative analysis of clinical outcomes with PIK3CA mutation (mut) status from a phase I/Ib study of GDC-0077 in patients (pts) with hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2-mBC)
    Jhaveri, Komal
    Juric, Dejan
    Varga, Andrea
    Turner, Nicolas
    Schmid, Peter
    Saura, Cristina
    Oliveira, Mafalda
    Krop, Ian E.
    Kalinsky, Kevin
    Italiano, Antoine
    Hamilton, Erika
    Gambardella, Valentina
    Cervantes, Andres
    Bedard, Philippe L.
    Liu, Bonnie P.
    Chen, Jessica W.
    Aimi, Junko
    Royer-Joo, Stephanie
    Schutzman, Jennifer L.
    Hutchinson, Katherine E.
    [J]. CANCER RESEARCH, 2021, 81 (04)
  • [7] INAVO121: Phase III study of inavolisib (INAVO) plus fulvestrant (FUL) vs. alpelisib (ALP) plus FUL in patients (pts) with hormone receptor-positive, HER2-negative (HR+, HER2-), PIK3CA-mutated (mut) locally advanced or metastatic breast cancer (LA/mBC)
    Juric, Dejan
    Kalinsky, Kevin
    Im, Seock-Ah
    Ciruelos, Eva
    Bianchini, Giampaolo
    Barrios, Carlos H., Sr.
    Jacot, William
    Schmid, Peter
    Loi, Sherene
    Rugo, Hope S.
    Craine, Veronica
    Hutchinson, Katherine E.
    Flechais, Aulde
    Thanopoulou, Eirini
    Harbeck, Nadia
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2024, 42 (16)
  • [8] INAVO121: Phase III study of inavolisib (INAVO) plus fulvestrant (FUL) vs. alpelisib (ALP) plus FUL in patients (pts) with hormone receptor-positive, HER2-negative (HR+, HER2-) PIK3CA-mutated (mut) locally advanced or metastatic breast cancer (LA/mBC)
    Juric, Dejan
    Kalinsky, Kevin
    Im, Seock-Ah
    Ciruelos, Eva M.
    Bianchini, Giampaolo
    Barrios, Carlos H.
    Jacot, William
    Schmid, Peter
    Loi, Sherene
    Rugo, Hope S.
    Craine, Veronica
    Hutchinson, Katherine E.
    Flechais, Aulde
    Thanopoulou, Eirini
    Harbeck, Nadia
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)
  • [9] SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA-mutant tumors
    Baselga, J.
    Cortes, J.
    De Laurentiis, M.
    Dieras, V.
    Harbeck, N.
    Hsu, J.
    Jin, H.
    Schimmoller, F.
    Wilson, T. R.
    Im, Y-H
    Jacot, W.
    Krop, I. E.
    Verma, S.
    [J]. CANCER RESEARCH, 2016, 76
  • [10] SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA-mutant tumors
    Baselga, J.
    Cortes, J.
    De laurentiis, M.
    Dent, S.
    Dieras, V.
    Harbeck, N.
    Hsu, J.
    Jin, H.
    Schimmoller, F.
    Wilson, T. R.
    Im, Y-H
    Jacot, W.
    Krop, I. E.
    Verma, S.
    [J]. CANCER RESEARCH, 2017, 77