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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial

Published date:
03/07/2023
Excerpt:
In the CT-P6 3.2 study, patients with HER2-positive early breast cancer were randomised to neoadjuvant chemotherapy with CT-P6 or reference trastuzumab...Corresponding 6-year survival rates in the CT-P6 and reference trastuzumab groups, respectively, were 0.96 (0.90-0.99) and 0.94 (0.87-0.97), 0.87 (0.78-0.92) and 0.89 (0.81-0.94), and 0.87 (0.78-0.92) and 0.89 (0.82-0.94)….Data from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years.
DOI:
10.1007/s40259-023-00582-w
Evidence Level:
Sensitive: B - Late Trials
Title:

Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial

Published date:
06/20/2021
Excerpt:
...biosimilar CT-P6 and trastuzumab following neoadjuvant therapy for patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer...CT-P6 and trastuzumab supports the equivalence in terms of efficacy established for the primary endpoint. CT-P6 was well tolerated, with comparable safety and immunogenicity to trastuzumab.
DOI:
10.1007/s10549-021-06240-5
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Gastroesophageal Junction Adenocarcinoma)
New
Excerpt:
Herzuma 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-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

Excerpt:
...- Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry)....
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Efficacy of CT-P6 (trastuzumab biosimilar) versus reference trastuzumab in combination with pertuzumab in HER2-positive early-stage breast cancer: Preclinical and real-life clinical data

Published date:
01/19/2022
Excerpt:
In BT-474 and SKBR3 HER2+ cells we found that CT-P6 alone or in combination with pertuzumab had the same negative effect on cell proliferation, colony formation and HER2 downregulation as well as downstream activation, as RTZ. Adding paclitaxel to these treatments increased their effectivity to a similar extent.
DOI:
10.1016/j.breast.2022.01.007