Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer (PLEASURABLE)
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ClinicalTrials.gov Identifier: NCT03772353 |
Recruitment Status :
Active, not recruiting
First Posted : December 11, 2018
Last Update Posted : March 7, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | December 10, 2018 | ||||
First Posted Date ICMJE | December 11, 2018 | ||||
Last Update Posted Date | March 7, 2023 | ||||
Actual Study Start Date ICMJE | May 12, 2019 | ||||
Estimated Primary Completion Date | June 10, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer | ||||
Official Title ICMJE | Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer: a Multi-center Phase Ib/II Study | ||||
Brief Summary | This is a single-center Ib / II study of triple targeted drug combination (endocrine therapy,novel HER2-targeted small molecule inhibitor pyrotinib and CDK4/6 inhibitor dalpiciclib(SHR6390) ) as a first or second line of therapy in patients with relapsed/metastatic hormone receptor positive and HER2-positive breast cancer. | ||||
Detailed Description | This is a single-center, single arm, open-label, run-in phase Ib / roll-over phase II study of endocrine therapy in combination with novel human epidermal growth factor receptor-2(HER2)-targeted tyrosine kinase Inhibitor pyrotinib and cyclin-dependent kinase 4/6(CDK4/6) Inhibitor dalpiciclib(SHR6390) in subjects with hormone receptor(HR)+/HER2+ relapsed or metastatic breast cancer. The study will enroll natural postmenopausal women, or women who have undergone bilateral oophorectomy.The phase Ib part of the study will determine safety and tolerability of the combination of endocrine therapy, pyrotinib and dalpiciclib to define that appropriate dose of dalpiciclib for phase II.Data from phase Ib showed the triplet of pyrotinib, dalpiciclib, andendocrine therapy had an acceptable safety profile and encouraging efficacy, potentially offering a chemotherapy-sparing treatment option for patients with HER2-positive/HR-positive MBC.Once the recommended regimen has been identified, subjects with the selected tumor type will be enrolled into expansion cohorts for the purpose of assessing efficacy and safety of the combination treatment. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Dalpiciclib combined with Pyrotinib and Endocrine therapy
Data from phase Ib showed the triplet of pyrotinib, SHR6390, and letrozole had an acceptable safety profile and encouraging efficacy, potentially offering a chemotherapy-sparing treatment option for patients with HER2-positive/HR-positive MBC. Based on DLTs and clinical efficacy, pyrotinib 320mg/d, SHR6390 125mg/d, and letrozole 2.5mg/d was declared as RP2D. The pharmacokinetic analysis had not yielded conclusive results and would involve more samples in phase II trial. Dalpiciclib combined with Pyrotinib and Endocrine therapy (treatment of physician's choice: letrozole or fulvestrant) ER+/HER2+ metastatic breast cancer patients eligible for first- or second-line treatment were enrolled to receive dalpiciclib combined with pyrotinib and endocrine therapy (treatment of physician's choice: letrozole or fulvestrant) Interventions:
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Publications * | Zhang J, Meng Y, Wang B, Wang L, Cao J, Tao Z, Li T, Yao W, Hu X. Dalpiciclib Combined With Pyrotinib and Letrozole in Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer (LORDSHIPS): A Phase Ib Study. Front Oncol. 2022 Mar 7;12:775081. doi: 10.3389/fonc.2022.775081. eCollection 2022. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
59 | ||||
Original Estimated Enrollment ICMJE |
32 | ||||
Estimated Study Completion Date ICMJE | December 10, 2025 | ||||
Estimated Primary Completion Date | June 10, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03772353 | ||||
Other Study ID Numbers ICMJE | PLEASURABLE | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Xichun Hu, Fudan University | ||||
Original Responsible Party | Xichun Hu, Fudan University, M.D | ||||
Current Study Sponsor ICMJE | Fudan University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Fudan University | ||||
Verification Date | March 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |