Description:
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is
superior to physician's choice in prolonging progression free survival.
Title
- Brief Title: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
- Official Title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
SYD985.002
- NCT ID:
NCT03262935
Conditions
Interventions
Drug | Synonyms | Arms |
---|
(vic-)trastuzumab duocarmazine | SYD985, Trastuzumab vc-seco-DUBA | (vic-)trastuzumab duocarmazine |
Physician's choice | Lapatinib (Lap), Capecitabine (Cap), Trastuzumab (T), Vinorelbine (Vino), Eribulin (Eri) | Physician's choice |
Purpose
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is
superior to physician's choice in prolonging progression free survival.
Detailed Description
This study is designed as a randomized, active-controlled, superiority study in patients with
unresectable locally advanced or metastatic HER2-positive breast cancer. The patients should
have had either progression during or after at least two HER2-targeting treatment regimens
for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab
emtansine treatment.
Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice
treatment until disease progression, unacceptable toxicity or study termination by the
Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy,
quality of life (QoL), and safety using standardized criteria.
Trial Arms
Name | Type | Description | Interventions |
---|
(vic-)trastuzumab duocarmazine | Experimental | SYD985, every 3 weeks (Q3W) | - (vic-)trastuzumab duocarmazine
|
Physician's choice | Active Comparator | Lap/Cap
T/Cap
T/Vino
T/Eri | |
Eligibility Criteria
Main Inclusion Criteria:
- Female patients with histologically-confirmed, unresectable locally advanced or
metastatic breast cancer;
- Patients should have had either progression during or after at least two
HER2-targeting treatment regimens for locally advanced or metastatic disease or
progression during or after (ado-)trastuzumab emtansine treatment for locally advanced
or metastatic disease;
- HER2-positive tumor status;
- Patients must have measurable or non-measurable disease that is evaluable per RECIST
1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Estimated life expectancy > 12 weeks at randomization;
- Adequate organ function and blood cell counts.
Main Exclusion Criteria:
- Current or previous use of a prohibited medication as listed in the protocol;
- History of infusion-related reactions and/or hypersensitivity to trastuzumab,
(ado-)trastuzumab emtansine;
- History of keratitis;
- Severe, uncontrolled systemic disease at screening;
- Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically
significant decrease in LVEF during previous treatment with trastuzumab or
(ado-)trastuzumab emtansine;
- Cardiac troponin value above the Upper Limit of Normal (ULN);
- History of clinically significant cardiovascular disease;
- Untreated brain metastases, symptomatic brain metastases, brain metastases requiring
steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to
randomization;
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest CT scan.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | Up to 2 years from baseline |
Safety Issue: | |
Description: | Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier. |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 2-year overall survival |
Safety Issue: | |
Description: | Overall survival is defined as the time from date of randomization to death due to any cause. |
Measure: | Objective Response Rate |
Time Frame: | Up to 2 years from baseline |
Safety Issue: | |
Description: | Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1. |
Measure: | Investigator assessed Progression Free Survival |
Time Frame: | Up to 2 years from baseline |
Safety Issue: | |
Description: | Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier. |
Measure: | Patient reported outcomes for health related quality of life |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Standard EORTC questionnaire |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Byondis B.V. |
Last Updated
June 2, 2021