Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03698383|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer Metastatic Breast Cancer||Drug: Trastuzumab biosimilars(Herzuma), Gedatolisib||Phase 2|
All the patients will be included in the final analysis, with a total of 62 patients to be enrolled.
Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal.
Tumor measurement and evaluation are going to be performed at every 6 weeks for the first 3 months, then at every 9 weeks till progression, and then follow-up evaluation at every 12 weeks thereafter end of study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Trastuzumab Biosimilar (Herzuma®) Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: Herzuma plus Gedatolisib||
Drug: Trastuzumab biosimilars(Herzuma), Gedatolisib
Other Name: Herzuma plus Gedatolisib
- Objective response rate [ Time Frame: within maximum 3 years ]the percentage of patients experiencing confirmed complete response (CR) and partial response (PR) assessed by RECIST criteria v.1.1
- Progression free survival [ Time Frame: within maximum 3 years ]the time from study entry until the first observation of disease progression according to the above schedule or death due to any cause
- Overall survival [ Time Frame: within maximum 3 years ]the time from study entry until death
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): NCT03698383
|Contact: Kyong Hwa Park, MD, PhDemail@example.com|
|Contact: Jung Yoon Choi, MDfirstname.lastname@example.org|
|Principal Investigator:||Kyong Hwa Park, MD, PhD||Korean Cancer Study Group|