Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: Pyrotinib combined with capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer |
Actual Study Start Date : | June 26, 2019 |
Estimated Primary Completion Date : | March 31, 2021 |
Estimated Study Completion Date : | May 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
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Drug: Pyrotinib combined with capecitabine
pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with trastuzumab resistance is defined as follows:
Progression during or within 12 months after treatment in neoadjuvant or adjuvant setting (at least 9 weeks of trastuzumab treatment); Or Progression during or within 6 months after treatment for locally advanced or metastatic disease in the first-line setting (at least 6 weeks of trastuzumab treatment).
Patients with adequate organ function before enrollment:
Exclusion Criteria:
Contact: Xichun Hu, MD, PhD | 021-64175590 | ycmnankai@126.com |
China | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, China, 200032 | |
Contact: Xichun Hu, M.D., Ph.D. 64175590 ext 5006 ycmnankai@126.com |
Principal Investigator: | Xichun Hu | Department of Oncology |
Tracking Information | |||||
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First Submitted Date ICMJE | June 27, 2019 | ||||
First Posted Date ICMJE | June 28, 2019 | ||||
Last Update Posted Date | June 28, 2019 | ||||
Actual Study Start Date ICMJE | June 26, 2019 | ||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: Estimated 12 months ] From enrollment to progression or death (for any reason)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer | ||||
Official Title ICMJE | Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer | ||||
Brief Summary | Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. This study is designed to evaluate the efficacy and safety of pyrotinib in combination with capecitabine in patients with HER2 positive locally advanced or metastatic breast cancer who had early failure on or after trastuzumab treatment. | ||||
Detailed Description | A multi-center, one-arm, open label design study, which is planned to enroll 100 patients with trastuzumab-resistant HER2-positive advanced breast cancer. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Breast Cancer | ||||
Intervention ICMJE | Drug: Pyrotinib combined with capecitabine
pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
|
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Study Arms ICMJE | Experimental: Pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Intervention: Drug: Pyrotinib combined with capecitabine
|
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Publications * | Not Provided | ||||
* 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 | Recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 31, 2022 | ||||
Estimated Primary Completion Date | March 31, 2021 (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 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04001621 | ||||
Other Study ID Numbers ICMJE | HR-BLTN-003 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Xichun Hu, Fudan University | ||||
Study Sponsor ICMJE | Fudan University | ||||
Collaborators ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Investigators ICMJE |
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PRS Account | Fudan University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |