Letrozole, Pyrotinib Combined With SHR6390 in Patients With HR+/HER2+ Relapsed/Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03772353|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole Drug: Pyrotinib Drug: SHR6390||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Study of Letrozole in Combination With Novel HER2-targeted Tyrosine Kinase Inhibitor Pyrotinib and CDK4/6 Inhibitor SHR6390 in Subjects With HR+/HER2+ Relapsed/Metastatic Breast Cancer|
|Actual Study Start Date :||May 12, 2019|
|Estimated Primary Completion Date :||June 12, 2020|
|Estimated Study Completion Date :||November 12, 2020|
Experimental: Letrozole Combined with Pyrotinib and SHR6390
During phase 1b part of this trial, treatment will be administered in cycles of 28 days and consist of letrozole 2.5 mg and pyrotinib 400 mg orally once daily in combination with SHR6390 (at protocol defined dose levels) po daily for 21 days followed by 7 days off. Once the recommended phase II dose (RP2D) has been determined, testing of this drug combination will be expanded in the phase II part to determine the progression-free survival (PFS) rate.
Letrozole, 2.5mg, PO daily (continuously)
Pyrotinib, 400mg, PO daily (continuously)
SHR6390 either 100mg,125mg, 150 mg PO daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
- The number of patients in the Phase 1b part of the study with any adverse events (AE). [ Time Frame: 2 years ]To measure safety and tolerability of SHR6390 used in combination with and letrozole and pyrotinib (phase Ib part) we will assess the incidence, nature and severity of all adverse events (AE) that occur on or after C1D1 of therapy, AE severities will be classified using the CTCAE criteria.
- The number of patients with progression-free survival (PFS) [ Time Frame: 2 years ]To measure efficacy of SHR6390 used in combination with letrozole and pyrotinib PFS (phase II part) will be assessed. PFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772353
|Contact: Xichun Hu, MD, PhD||64175590 ext firstname.lastname@example.org|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, China, 200032|
|Contact: Xichun Hu, M.D., Ph.D. 64175590 ext 5006 email@example.com|