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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Jivadco (trastuzumab duocarmazine) (HER2-targeted antibody-drug conjugate, DNA replication inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
386MO - Trastuzumab duocarmazine versus physician's choice therapy in pre-treated HER2-positive metastatic breast cancer: Final results of the phase III TULIP trial
Published date:
10/16/2023
Excerpt:
T-Duo showed a meaningful and statistically significant improvement in PFS in patients with pre-treated HER2-positive MBC. The final OS results confirm a trend towards a numerically prolonged OS (statistically non-significant) in the T-Duo group compared with PC group. Safety was aligned with the primary analysis, with no new signals identified.
Trial ID:
Source:
Title:
LBA15 - Primary outcome of the phase III SYD985.002/TULIP trial comparing [vic-]trastuzumab duocarmazine to physician’s choice treatment in patients with pre-treated HER2-positive locally advanced or metastatic breast cancer
Published date:
09/13/2021
Excerpt:
Centrally reviewed median PFS was 7.0 months [95% CI 5.4-7.2] for SYD985 and 4.9 mo [4.0-5.5] for PC (HR 0.64 [0.49-0.84]; p = 0.002)….Treatment with SYD985 significantly improved PFS in comparison with standard PC and may provide a new treatment option for patients with pre-treated locally advanced or metastatic HER2-positive MBC.
Trial ID:
Source:
Title:
Byondis Announces Positive Topline Results of Pivotal Phase III TULIP® Study in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Published date:
06/08/2021
Excerpt:
The trial compared the efficacy and safety of the company's antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) to physician's choice treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC)....met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over physician's choice.
Trial ID:
Source:
Title:
Synthon’s [vic-]trastuzumab duocarmazine (SYD985) granted FDA Fast Track designation for pre-treated HER2-positive metastatic breast cancer
Published date:
01/25/2018
Excerpt:
...Synthon Biopharmaceuticals (‘Synthon’) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its investigational anti-HER2 antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985). This designation is for treating patients diagnosed with HER2-positive metastatic breast cancer (MBC)...
Source:
Title:
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- HER2-positive tumor status;...
Trial ID:
Source:
Title:
Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study
Published date:
06/27/2019
Excerpt:
In the breast cancer dose-expansion cohorts, 16 (33%, 95% CI 20·4-48·4) of 48 assessable patients with HER2-positive breast cancer achieved an objective response (all partial responses) according to RECIST.
DOI:
10.1016/S1470-2045(19)30328-6
Trial ID:
Source:
Title:
A phase I expansion cohorts study of SYD985 in heavily pretreated patients with HER2-positive or HER2-low metastatic breast cancer.
Published date:
05/16/2018
Excerpt:
SYD985 shows promising efficacy in heavily pretreated patients with breast cancer, in both HER2-positive and HER2-low tumors…
DOI:
10.1200/JCO.2018.36.15_suppl.1014
Trial ID:
