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Shigehira Saji
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Journal Articles

Abstract CT256: EmpowHER-303: A phase 3 study of zanidatamab vs trastuzumab with physician’s choice of chemotherapy in patients with HER2+ metastatic breast cancer whose disease progressed on trastuzumab deruxtecan

Free
Sara M. Tolaney, Javier Cortes, Erika Hamilton, Hiroji Iwata, Yeon Hee Park, Debasish Tripathy, Romualdo Barroso-Sousa, Giuseppe Curigliano, Nadia Harbeck, Hope S. Rugo, Shanu Modi, Joshua Drago, Stephanie L. Graff, Carlos Barrios, Hartmut Kristeleit, Barbara Pistilli, Philippe Aftimos, Shigehira Saji, Angelos Koutras, Debasis Chakrabarti, Kamalnayan Bhatt, George Cai, Xiaoyan Wang, Sara Hurvitz
Journal: Cancer Research
Cancer Res (2025) 85 (8_Supplement_2): CT256.
https://doi.org/10.1158/1538-7445.AM2025-CT256
Published: 25 April 2025
View articletitled, Abstract CT256: EmpowHER-303: A phase 3 study of zanidatamab vs trastuzumab with physician’s choice of chemotherapy in patients with HER2+ metastatic breast cancer whose disease progressed on trastuzumab deruxtecan
Journal Articles

Abstract GS01-05: Pembrolizumab + Olaparib vs Pembrolizumab + Chemotherapy After Induction With Pembrolizumab + Chemotherapy for Locally Recurrent Inoperable or Metastatic TNBC: Randomized Open-Label Phase 2 KEYLYNK-009 Study

Free
Hope Rugo, Mark Robson, Seock-Ah Im, Florence Dalenc, Eduardo Yañez Ruiz, Young-Hyuck Im, Sergii Kulyk, Oleksandr Dudnichenko, Néstor Llinás-Quintero, Shigehira Saji, Yasuo Miyoshi, Nadia Harbeck, Li Fan, Jaime Mejia, Vassiliki Karantza, David Cescon
Journal: Cancer Research
Cancer Res (2024) 84 (9_Supplement): GS01-05.
https://doi.org/10.1158/1538-7445.SABCS23-GS01-05
Published: 02 May 2024
View articletitled, Abstract GS01-05: Pembrolizumab + Olaparib vs Pembrolizumab + Chemotherapy After Induction With Pembrolizumab + Chemotherapy for Locally Recurrent Inoperable or Metastatic TNBC: Randomized Open-Label Phase 2 KEYLYNK-009 Study
Journal Articles

Abstract GS01-03: Adding atezolizumab to adjuvant chemotherapy for stage II and III triple-negative breast cancer is unlikely to improve efficacy: interim analysis of the ALEXANDRA/IMpassion030 phase 3 trial

Free
Michail Ignatiadis, Andrew Bailey, Heather McArthur, Sarra El-Abed, Evandro de Azambuja, Otto Metzger, Steve Chui, Max Dieterich, Thomas Perretti, Guenther Steger, Jacek Jassem, Soo Chin Lee, Michaela Higgins, José Zarbá, Marcus Schmidt, Henry Gomez, Angel Guerrero-Zotano, Luca Moscetti, Joanne Win Yang Chiu, Carter DuFrane, Vanessa Honvault, Rosa Altarcheh, Luciana Molinero, Andrew Ellingson, Elisabetta Munzone, Noa Efrat Ben-Baruch, Emilio Bajetta, Shinji Ohno, Seock-Ah Im, Gustavo Werutsky, Einav Gal-Yam, Xavier Gonzalez-Farré, Ling-Ming Tseng, William Jacot, Oleg Gluz, Zhimin Shao, Yaroslav Shparyk, Ivan Sinielnikov, Zimina Anastasia, Aleksandr Vasiliev, Esther Shearer-Kang, Eric Winer, Diogo Martins-Branco, Shona Fielding, David Cameron, Giuseppe Viale, Shigehira Saji, Richard Gelber, Martine Piccart
Journal: Cancer Research
Cancer Res (2024) 84 (9_Supplement): GS01-03.
https://doi.org/10.1158/1538-7445.SABCS23-GS01-03
Published: 02 May 2024
View articletitled, Abstract GS01-03: Adding atezolizumab to adjuvant chemotherapy for stage II and III triple-negative breast cancer is unlikely to improve efficacy: interim analysis of the ALEXANDRA/IMpassion030 phase 3 trial
Journal Articles

Abstract PO1-05-06: Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26)

Free
Hiroko Bando, Mari Oba, Aya Ueda, Kaori Terata, Mihoko Doi, Shigenori Nagai, Masaya Hattori, Ken-Ichi Watanabe, Nobuko Tamura, Manabu Futamura, Kei Koizumi, Naoki Niikura, Tempei Miyaji, Yasuaki Muramatsu, Linghua Xu, Norikazu Masuda, Shigehira Saji
Journal: Cancer Research
Cancer Res (2024) 84 (9_Supplement): PO1-05-06.
https://doi.org/10.1158/1538-7445.SABCS23-PO1-05-06
Published: 02 May 2024
View articletitled, Abstract PO1-05-06: Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26)
Journal Articles

Abstract 5203: Identification of prognostic and predictive biomarkers for palbociclib add-on therapy using cancer panel sequencing of cell-free DNA in patients with HR-positive HER2-negative advanced and metastatic breast cancer with fulvestrant resistance

Free
Takashi Takeshita, Takayuki Iwamoto, Naoki Niikura, Kenichi Watanabe, Yuichiro Kikawa, Kokoro Kobayashi, Nobutaka Iwakuma, Takuho Okamura, Hiroshi Tada, Shinji Ozaki, Toshitaka Okuno, Uhi Toh, Yutaka Yamamoto, Michiko Tsuneizumi, Hiroshi Ishiguro, Norikazu Masuda, Shigehira Saji
Journal: Cancer Research
Cancer Res (2024) 84 (6_Supplement): 5203.
https://doi.org/10.1158/1538-7445.AM2024-5203
Published: 22 March 2024
View articletitled, Abstract 5203: Identification of prognostic and predictive biomarkers for palbociclib add-on therapy using cancer panel sequencing of cell-free DNA in patients with HR-positive HER2-negative advanced and metastatic breast cancer with fulvestrant resistance
Journal Articles

Abstract P1-01-05: Adjuvant S-1 plus endocrine therapy for estrogen receptor-positive, HER2-negative, primary breast cancer: updated overall survival analysis from the POTENT trial

Free
Masahiro Takada, Shigehira Saji, Takayuki Ueno, Norikazu Masuda, Hiroshi Ishiguro, Takanori Ishida, Toshiaki Saeki, Shigeru Imoto, Shinji Ohno, Hiroji Iwata, Tomoharu Sugie, Kenjiro Aogi, Hirofumi Mukai, Shin Takayama, Nobuaki Sato, Yuichiro Kai, Masahiro Kitada, Rikiya Nakamura, Yutaka Matsuyama, Masakazu Toi
Journal: Cancer Research
Cancer Res (2023) 83 (5_Supplement): P1-01-05.
https://doi.org/10.1158/1538-7445.SABCS22-P1-01-05
Published: 01 March 2023
View articletitled, Abstract P1-01-05: Adjuvant S-1 plus endocrine therapy for estrogen receptor-positive, HER2-negative, primary breast cancer: updated overall survival analysis from the POTENT trial
Journal Articles

Abstract P2-03-15: Retrospective study using database for the effectiveness of medroxyprogesterone acetate in patients with ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study

Free
Kaho Utsunomiya, Hidetoshi Kawaguchi, Yutaka Yamamoto, Shigehira Saji, Norikazu Masuda, Takahiro Nakayama, Kenjiro Aogi, Keisei Anan, Shoichiro Ohtani, Nobuaki Sato, Toshimi Takano, Eriko Tokunaga, Seigo Nakamura, Yoshie Hasegawa, Masaya Hattori, Tomomi Fujisawa, Satoshi Morita, Miki Yamaguchi, Toshinari Yamashita, Daisuke Yotsumoto, Masakazu Toi, Shinji Ohno
Journal: Cancer Research
Cancer Res (2023) 83 (5_Supplement): P2-03-15.
https://doi.org/10.1158/1538-7445.SABCS22-P2-03-15
Published: 01 March 2023
View articletitled, Abstract P2-03-15: Retrospective study using database for the effectiveness of medroxyprogesterone acetate in patients with ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study
Journal Articles

Abstract OT1-03-05: TROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-(L)1 therapy

Free
Rebecca Dent, David W. Cescon, Thomas Bachelot, Kyung Hae Jung, Zhi-Ming Shao, Shigehira Saji, Tiffany A. Traina, Petra Vuković, Darlington Mapiye, Micah Maxwell, Peter Schmid, Javier Cortés
Journal: Cancer Research
Cancer Res (2023) 83 (5_Supplement): OT1-03-05.
https://doi.org/10.1158/1538-7445.SABCS22-OT1-03-05
Published: 01 March 2023
View articletitled, Abstract OT1-03-05: TROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-(L)1 therapy
Journal Articles

Abstract OT2-03-02: lidERA Breast Cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy in patients with estrogen receptor+, HER2– early breast cancer

Free
Peter Schmid, Charles E. Geyer Jr, Nadia Harbeck, Mothaffar Rimawi, Sara Hurvitz, Miguel Martín, Sherene Loi, Shigehira Saji, Kyung Hae Jung, Gustavo Werutsky, Daniil L. Stroyakovsky, Vanesa López-Valverde, Michael Davis, Tanja Badovinac Crnjevic, Pablo D. Perez-Moreno, Aditya Bardia
Journal: Cancer Research
Cancer Res (2023) 83 (5_Supplement): OT2-03-02.
https://doi.org/10.1158/1538-7445.SABCS22-OT2-03-02
Published: 01 March 2023
View articletitled, Abstract OT2-03-02: lidERA Breast Cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy in patients with estrogen receptor+, HER2– early breast cancer
Journal Articles

Abstract OT2-11-09: Lidera breast cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy (ET) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+/HER2- EBC)

Free
Aditya Bardia, Peter Schmid, Nadia Harbeck, Mothaffar F Rimawi, Sara A Hurvitz, Sherene Loi, Shigehira Saji, Kyung Hae Jung, Gustavo Werutsky, Daniil Stroyakovskii, Vanesa López-Valverde, David Tesarowski, Chenglin Ye, Michael Davis, Tanja Badovinac Crnjevic, Pablo Diego Perez-Moreno, Charles E Geyer, Jr
Journal: Cancer Research
Cancer Res (2022) 82 (4_Supplement): OT2-11-09.
https://doi.org/10.1158/1538-7445.SABCS21-OT2-11-09
Published: 15 February 2022
View articletitled, Abstract OT2-11-09: Lidera breast cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy (ET) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+/HER2- EBC)
Journal Articles

Abstract OT1-18-01: A randomized controlled phase III study of bevacizumab and paclitaxel in combination with atezolizumab as a treatment for patients with locally advanced or metastatic hormone receptor-positive HER2 negative breast cancer: JCOG1919E/AMBITION study

Free
Fumikata Hara, Makiko Ono, Shigehisa Kitano, Shigehira Saji, Akihiko Shimomura, Takashi Yamanaka, Takayuki Kadoya, Mitsuya Ito, Hiroko Bando, Hiroyuki Yasojima, Keita Sasaki, Tomoko Kataoka, Tadahiko Shien, Kan Yonemori, Hiroji Iwata
Journal: Cancer Research
Cancer Res (2022) 82 (4_Supplement): OT1-18-01.
https://doi.org/10.1158/1538-7445.SABCS21-OT1-18-01
Published: 15 February 2022
View articletitled, Abstract OT1-18-01: A randomized controlled phase III study of bevacizumab and paclitaxel in combination with atezolizumab as a treatment for patients with locally advanced or metastatic hormone receptor-positive HER2 negative breast cancer: JCOG1919E/AMBITION study
Journal Articles

Abstract LB162: Evaluation of tumor immune biomarkers with pathologic complete response (pCR) in patients receiving atezolizumab + chemotherapy in early triple negative breast cancer (eTNBC): exploratory analyses from the IMpassion031 study

Free
Luciana L. Molinero, Elizabeth A. Mittendorf, Hong Zhang, Carlos H. Barrios, Shigehira Saji, Kyung Hae Jung, Shilpen Patel, Ching-Wei Chang, Mario Liste-Hermoso, Stephen Y. Chui, Nadia Harbeck
Journal: Cancer Research
Cancer Res (2021) 81 (13_Supplement): LB162.
https://doi.org/10.1158/1538-7445.AM2021-LB162
Published: 01 July 2021
View articletitled, Abstract LB162: Evaluation of tumor immune biomarkers with pathologic complete response (pCR) in patients receiving atezolizumab + chemotherapy in early triple negative breast cancer (eTNBC): exploratory analyses from the IMpassion031 study
Journal Articles

Abstract PD12-11: Patient-reported outcomes from the Phase III IMpassion031 trial of neoadjuvant atezolizumab + chemotherapy in early triple-negative breast cancer

Free
Elizabeth Mittendorf, Nadia Harbeck, Hong (Amy) Zhang, Shigehira Saji, Kyung Hae Jung, Sheetal Patel, Shilpen Patel, Anh Nguyen Duc, Mario Liste-Hermoso, Stephen Y Chui, Carlos H Barrios
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): PD12-11.
https://doi.org/10.1158/1538-7445.SABCS20-PD12-11
Published: 15 February 2021
View articletitled, Abstract PD12-11: Patient-reported outcomes from the Phase III IMpassion031 trial of neoadjuvant atezolizumab + chemotherapy in early triple-negative breast cancer
Journal Articles

Abstract PD3-11: A randomized, open-label, phase III trial of pertuzumab re-treatment in HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab, and chemotherapy: The Japan Breast Cancer Research Group-M05 (PRECIOUS) study

Free
Yutaka Yamamoto, Hiroji Iwata, Taira Naruto, Norikazu Masuda, Masato Takahashi, Tetsuhiro Yoshinami, Takayuki Ueno, Tatsuya Toyama, Takashi Yamanaka, Toshimi Takano, Masahiro Kashiwaba, Koichiro Tsugawa, Yoshie Hasegawa, Kenji Tamura, Hiroshi Tada, Fumikata Hara, Shigehira Saji, Satoshi Morita, Masakazu Toi, Shinji Ohno, Japan Breast Cancer Research Group
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): PD3-11.
https://doi.org/10.1158/1538-7445.SABCS20-PD3-11
Published: 15 February 2021
View articletitled, Abstract PD3-11: A randomized, open-label, phase III trial of pertuzumab re-treatment in HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab, and chemotherapy: The Japan Breast Cancer Research Group-M05 (PRECIOUS) study
Journal Articles

Abstract PS5-06: Prospective testing for PIK3CA/AKT1/PTEN alterations in tumor tissue from 1440 patients with advanced hormone receptor-positive HER2-negative breast cancer (HR+/HER2- BC) or triple-negative breast cancer (TNBC) screened for the IPATunity130 randomized phase 3 trial

Free
Heidi Savage, Wendy Lin, Mafalda Oliveira, Carlos Barrios, Joyce O’Shaughnessy, Nicholas Turner, Rebecca Dent, Steven J Isakoff, Shigehira Saji, Qinshu Lian, Denise Bradley, Sarah-Jayne Reilly, Heather Hinton, Matthew J Wongchenko, Aruna Mani, Sung-Bae Kim
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): PS5-06.
https://doi.org/10.1158/1538-7445.SABCS20-PS5-06
Published: 15 February 2021
View articletitled, Abstract PS5-06: Prospective testing for PIK3CA/AKT1/PTEN alterations in tumor tissue from 1440 patients with advanced hormone receptor-positive HER2-negative breast cancer (HR+/HER2- BC) or triple-negative breast cancer (TNBC) screened for the IPATunity130 randomized phase 3 trial
Journal Articles

Abstract PD1-09: Safety and efficacy results from the phase 1/2 study of U3-1402, a human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC)

Free
Ian Krop, Kan Yonemori, Shunji Takahashi, Kenichi Inoue, Takahiro Nakayama, Hiroji Iwata, Tatsuya Toyama, Yutaka Yamamoto, Masato Takahashi, Akihiko Osaki, Shigehira Saji, Yasuaki Sagara, Joyce O’Shaughnessy, Tiffany Traina, Shoichi Ohwada, Zhenhao Qi, Yang Qiu, Hiroshi Onuma, Om Sharma, Sabeen Mekan, Norikazu Masuda
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): PD1-09.
https://doi.org/10.1158/1538-7445.SABCS20-PD1-09
Published: 15 February 2021
View articletitled, Abstract PD1-09: Safety and efficacy results from the phase 1/2 study of U3-1402, a human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC)
Journal Articles

Abstract OT-30-01: KEYLYNK-009: A phase 2/3, open-label, randomized study of pembrolizumab plus olaparib vs pembrolizumab plus chemotherapy after induction with first-line pembrolizumab plus chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC)

Free
Hope Rugo, Antonio Llombart-Cussac, Fabrice Andre, Mark E. Robson, Shigehira Saji, Nadia Harbeck, Peter Schmid, David Cescon, Jin Seok Ahn, Rita Nanda, Li Fan, Jaime Alberto Mejia, Vassiliki Karantza, Aditya Bardia
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): OT-30-01.
https://doi.org/10.1158/1538-7445.SABCS20-OT-30-01
Published: 15 February 2021
View articletitled, Abstract OT-30-01: KEYLYNK-009: A phase 2/3, open-label, randomized study of pembrolizumab plus olaparib vs pembrolizumab plus chemotherapy after induction with first-line pembrolizumab plus chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC)
Journal Articles

Abstract GS3-02: Patient-reported outcomes (PROs) from the Ph 3 IMpassion031 trial of neoadjuvant (NA) atezolizumab + chemo in early triple-negative breast cancer (eTNBC)

Free
Elizabeth A. Mittendorf, Nadia Harbeck, Hong Zhang, Shigehira Saji, Kyung Hae Jung, Sheetal Patel, Shilpen Patel, Anh Nguyen Duc, Mario Liste-Hermoso, Stephen Y. Chui, Carlos H. Barrios
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): GS3-02.
https://doi.org/10.1158/1538-7445.SABCS20-GS3-02
Published: 15 February 2021
View articletitled, Abstract GS3-02: Patient-reported outcomes (PROs) from the Ph 3 IMpassion031 trial of neoadjuvant (NA) atezolizumab + chemo in early triple-negative breast cancer (eTNBC)
Journal Articles

Abstract GS3-04: Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): primary results from IPATunity130 Cohort A

Free
Rebecca Dent, Sung-Bae Kim, Mafalda Oliveira, Carlos Barrios, Joyce O’Shaughnessy, Steven J Isakoff, Shigehira Saji, Ruffo Freitas-Junior, Manuel Philco, Igor Bondarenko, Qinshu Lian, Denise Bradley, Heather Hinton, Matthew J Wongchenko, Aruna Mani, Nicholas Turner
Journal: Cancer Research
Cancer Res (2021) 81 (4_Supplement): GS3-04.
https://doi.org/10.1158/1538-7445.SABCS20-GS3-04
Published: 15 February 2021
View articletitled, Abstract GS3-04: Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): primary results from IPATunity130 Cohort A
Journal Articles

Abstract 2913: Entinostat (KHK2375), class I histone deacetylase inhibitor, regulates human Treg function by decreasing Foxp3 expression and effector Treg population

Free
Hiromichi Kosaka, Yozo Nishimura, Ayumi Kaneda, Norikazu Masuda, Kenji Tamura, Shigehira Saji, Hiroji Iwata, Kiyotoshi Mori
Journal: Cancer Research
Cancer Res (2020) 80 (16_Supplement): 2913.
https://doi.org/10.1158/1538-7445.AM2020-2913
Published: 15 August 2020
View articletitled, Abstract 2913: Entinostat (KHK2375), class I histone deacetylase inhibitor, regulates human Treg function by decreasing Foxp3 expression and effector Treg population