Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early 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: NCT03433313|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: EG12014 Drug: Herceptin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||August 5, 2020|
|Estimated Study Completion Date :||July 31, 2021|
Epirubicin and cyclophosphamide followed by EG12014 plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Active Comparator: Herceptin
Epirubicin and cyclophosphamide followed by Herceptin plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
- Determination of pathologic complete response (pCR) at time of surgery [ Time Frame: At the time of surgery (12 weeks after completion of neoadjuvant chemotherapy) ]pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes
- pCR at the time of surgery [ Time Frame: At the time of surgery (12 weeks after completion of neoadjuvant chemotherapy) ]pCR is defined as the absence of residual invasive cancer and of DCIS (ypT0 ypN0) from breast tissue and sentinel/axillary lymph nodes, as assessed by central laboratory
- Event-free survival (EFS) up to end of study (EOS) [ Time Frame: Randomization to date of progression or end of study (up to approximately 72 weeks) or death ]EFS is defined as time from initial randomization to the date when disease recurrence or progression (local, regional, distant or contralateral) is diagnosed according to institutional standard, or date of death of any cause, whichever is earlier
- Overall response (OR) prior to surgery [ Time Frame: At screening and prior to surgery (12 weeks after completion of neoadjuvant chemotherapy) ]Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1
- Overall survival (OS) up to End of Study (EOS) [ Time Frame: Randomization to end of study (up to approximately 72 weeks) or death ]OS up to EOS is defined as time from the date of initial randomization to the date of death
- Incidence of AEs [ Time Frame: From time of informed consent to end of study (up to approximately 72 weeks) or death ]Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities
- Evaluation of Immunogenicity of EG12014 and Herceptin [ Time Frame: End of treatment (up to ~55 weeks) ]Titer of anti-drug antibodies (ADA)
- Measure serum trastuzumab concentration [ Time Frame: Before the first infusion of study drug, during neoadjuvant treatment (at ~6 weeks and ~12 weeks of treatment), during adjuvant treatment (every 4 cycles [3 weeks/cycle] for up to 12 months), and End of Treatment (EOT) (up to ~55 weeks) ]Measure serum trastuzumab concentration for EG12014 and Herceptin arms
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): NCT03433313
|Contact: Udo Kiessling, MD PhD||+49 176 firstname.lastname@example.org|
Show 88 Study Locations