Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Trastuzumab and Neratinib, Followed by Neratinib Monotherapy
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|ClinicalTrials.gov Identifier: NCT03094052|
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer||Drug: Neratinib Drug: Trastuzumab Drug: Crofelemer Drug: Loperamide||Phase 2|
This is an open-label adjuvant/post neoadjuvant single arm phase 2 trial.
Patients will receive:
Neratinib 240 mg orally once a day for up to 52 weeks while receiving concurrent trastuzumab. After the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib will continue as monotherapy for 12 months. Neratinib is to be taken continuously in 21-day cycles with no rest between cycles unless related to toxicity.
Intensive daily loperamide prophylaxis for the first 2 cycles and then as needed.
Crofelemer 125 mg bid for the first two cycles then as needed.
Each cycle is 21 days. Clinic visits and laboratory studies are planned on day 1 of every cycle for the first 4 cycles, then q4 cycles thereafter. An end of treatment visit will occur 28 days after the last dose of neratinib. Patients who permanently discontinue treatment due to unacceptable toxicity will be followed-up for 28 days after the last dose of neratinib.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label adjuvant/post-neoadjuvant single arm phase 2 trial. There will be 23 patients recruited. If pertuzumab is approved in the adjuvant setting during the course of the study, the protocol will be amended to allow pertuzumab. This trial will open as a single-institution trial at UCSF and expand to include 1-2 other sites as needed.|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early Stage HER2+ Breast Cancer Treated With Adjuvant Trastuzumab and Neratinib Followed by Neratinib Monotherapy, and Intensive Anti-diarrhea Prophylaxis|
|Actual Study Start Date :||January 4, 2017|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 2, 2020|
Experimental: Neratinib, trastuzumab, crofelemer, loperamide
- Incidence of grade 3 or greater diarrhea with 2 cycles (6 weeks) of prophylactic loperamide and crofelemer, according to NCI CTCAE Version 4.0 [ Time Frame: 2 cycles (6 weeks) ]
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): NCT03094052
|Contact: Chiara Wabl||415-353-7517||Chiara.Wabl@ucsf.edu|
|Contact: Ivy Wong||415-353-7873||Ivy.Wong@ucsf.edu|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Jo Chien 877-827-3222 email@example.com|
|Principal Investigator: Jo Chien, MD|
|Principal Investigator:||Jo Chien, MD||University of California, San Francisco|