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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Ontruzant (trastuzumab-dttb) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial
Published date:
04/06/2023
Excerpt:
Five-year EFS rates were 79.8% (95% CI, 74.8%-84.9%) in the SB3 group and 75.0% (95% CI, 69.7%-80.3%) in the TRZ group, and OS rates were 92.5% (95% CI, 89.2%-95.7%) in the SB3 group and 85.4% (95% CI, 81.0%-89.7%) in the TRZ group….In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer.
DOI:
10.1001/jamanetworkopen.2023.5822
Trial ID:
Source:
Title:
Four-year follow-up of a phase III study comparing SB3 (trastuzumab biosimilar) and reference trastuzumab in HER2-positive early or locally advanced breast cancer in neoadjuvant setting.
Published date:
05/13/2020
Excerpt:
After completing neoadjuvant-adjuvant therapy in patients with HER2 positive early breast cancer, patients from selected countries participated in a 5-year follow-up study of a phase III trial...4-year EFS rates were 83.4% for SB3 and 80.7% for TRZ with a HR of 0.77 [95% CI 0.47, 1.27]. 4-year OS rates were 94.3% for SB3 and 89.6% for TRZ with a HR of 0.53 [95% CI 0.24, 1.16].
DOI:
10.1200/JCO.2020.38.15_suppl.578
Trial ID:
Source:
Title:
Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer
Excerpt:
This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference TRZ in patients with human epidermal growth factor receptor 2–positive early breast cancer in the neoadjuvant setting...Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide)...Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively.
Secondary therapy:
FEC-T
DOI:
10.1200/JCO.2017.74.0126
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
(Approved for Gastroesophageal Junction Adenocarcinoma)
New
Excerpt:
Ontruzant in combination with capecitabine or 5‑fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Source:
Title:
Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)
Excerpt:
...Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion....
Trial ID:
Source:
Title:
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Excerpt:
...HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+...
Trial ID:
More C2 evidence
Source:
Title:
This is a trial for female patients diagnosed with early breast cancer who are planned to receive chemotherapy in combination with an anti-HER2 antibody before breast surgery. During this study all patients will receive a standard chemotherapy according to local in-house standard. Additionally all patients will receive the antibody Ontruzant®, a trastuzumab biosimilar. Only women with HER2 positive breast cancer will be allowed to participate in this study. Diese Studie richtet sich an Patientinnen, die an frühem HER2neu positiven Brustkrebs erkrankt sind und bei denen eine Chemotherapie in Kombination mit einem Antikörper gegen den HER2-Rezeptor vor der Operation geplant ist. Im Rahmen der Studie erhalten alle Patientinnen eine Standard-Chemotherapie, wie sie auch im Rahmen der klinischen Routine durchgeführt werden würde. Zusätzlich erhalten die Patientinen den Antikörper Ontruzant®. Ontruzant ist ein Trastuzumab-Biosimilar.
Excerpt:
...Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.5. ...
Trial ID:
Less C2 evidence
Source:
Title:
Additional one-year follow-up study to evaluate safety and survival in patients who have completed neoadjuvant-adjuvant treatment with SB3 (trastuzumab biosimilar) or reference trastuzumab in HER2-positive early or locally advanced breast cancer.
Published date:
05/16/2018
Excerpt:
Patients with HER2 positive early or locally advanced breast cancer were randomly assigned to receive 8 cycles of SB3 or TRZ in neoadjuvant setting concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide)....At 24 months, EFS rates (SB3, 96.7%; TRZ 94.3%) and OS rates (SB3, 100.0%; TRZ, 99.4%) were comparable.
Secondary therapy:
FEC-T
DOI:
10.1200/JCO.2018.36.15_suppl.e12631
Trial ID:
