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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Kanjinti (trastuzumab-anns) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial
Excerpt:
We compared the clinical safety and efficacy of ABP 980 with that of trastuzumab in women with HER2-positive early breast cancer….Patients received neoadjuvant therapy with a loading dose (8 mg/kg) of ABP 980 or trastuzumab plus paclitaxel 175 mg/m2 in a 90 min intravenous infusion...Pathological complete response was recorded in 172 (48%, 95% CI 43-53) of 358 patients in the ABP 980 group and 137 (41%, 35-46) of 338 in the trastuzumab group (risk difference 7·3%, 90% CI 1·2-13·4; RR 1·188, 90% CI 1·033-1·366)...
Secondary therapy:
paclitaxel
DOI:
10.1016/S1470-2045(18)30241-9
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
(Approved for Gastroesophageal Junction Adenocarcinoma)
New
Excerpt:
Kanjinti 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 gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Source:
Title:
A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer
Excerpt:
...HER2 positive disease defined as: 3+ overexpression by immunohistochemistry (IHC) or HER2 amplification by fluorescence in situ hybridization (FISH)...
Trial ID:
