Phase 3
Completed N=437
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT03262935 ↗Enrolled (actual)
437
Serious AEs
15.3%
Results posted
Oct 2023
Primary outcomePrimary: Progression Free Survival — 7.0; 4.9 months — p==0.002
◆ Published Evidence
Established
32citations · ~32 / year
Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP).
Summary
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
Linked Publications
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Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
7.0; 4.9 | =0.002 sig |
| SECONDARY Overall Survival |
21.0; 19.5 | =0.236 |
| SECONDARY Objective Response Rate |
27.8; 29.5 | =0.732 |
| SECONDARY Investigator Assessed Progression Free Survival |
6.9; 4.6 | <0.001 sig |
| SECONDARY Patient Reported Outcomes for Health Related Quality of Life |
0.17; -3.88; -1.88; -2.99; -2.48; -9.01 | 0.473 |
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.
Data sourced from ClinicalTrials.gov (NCT03262935) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.