Ji, Yan http://orcid.org/0000-0001-9569-0574
Yartsev, Vitaly
Quinlan, Michelle
Serra, Paolo
Wang, Yingbo
Chakraborty, Abhijit
Miller, Michelle
Clinical trials referenced in this document:
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
Documents that mention this clinical trial
First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2− advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
https://doi.org/10.1007/s10549-017-4658-x
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3).
https://doi.org/10.1200/jco.2024.42.16_suppl.1012
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
6ER-004 Preliminary clinical response of ribociclib as a single agent in advanced breast cancer: in search of new therapeutic indications
https://doi.org/10.1136/ejhpharm-2020-eahpconf.439
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
6ER-004 Preliminary clinical response of ribociclib as a single agent in advanced breast cancer: in search of new therapeutic indications
https://doi.org/10.1136/ejhpharm-2020-eahpconf.439
Documents that mention this clinical trial
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
https://doi.org/10.1007/s40262-022-01206-2
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Accepted: 19 December 2022
First Online: 17 February 2023
Declarations
:
: The studies were supported by Novartis Pharmaceuticals Corporation, who also funded medical writing assistance.
: Yan Ji, Vitaly Yartsev, Michelle Quinlan, Yingbo Wang, Paolo Serra, Abhijit Chakraborty, and Michelle Miller are employees of Novartis and hold stock in the company.
: All studies were conducted according to the relevant ethical principles, and were approved by the local ethics committee.
: Written informed consent was obtained from all patients participating in the study.
: Not applicable (no personal data were reported).
: Novartis will not provide access to patient-level data, if there is a reasonable likelihood that individual patients could be re-identified. Phase I studies, by their nature, present a high risk of patient re-identification; therefore, patient individual results for phase I studies cannot be shared. In addition, clinical data, in some cases, have been collected subject to contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access under these provisions. Where co-development agreements or other legal restrictions prevent companies from sharing particular data, companies will work with qualified requestors to provide summary information where possible.
: SAS<sup>®</sup> version 9.4 (Cary, NC, USA); Phoenix WinNonlin™ version 6.4 (Pharsight, Mountain View, CA, USA).
: YJ, MM, VY, and AC designed the research. YJ and VY supported in the acquisition of data and data curation. YJ, MQ, PS, YW, and VY analyzed, interpreted, and validated the data. All authors wrote or reviewed the manuscript. YJ, MQ, YW, PS, and VY provided administrative, technical, or material support. YJ, AC, and MM supervised the development of the manuscript.