Trial reportESMO open2026
TQB2440 compared with reference pertuzumab for HER2-positive, ER/PgR-negative, early or locally advanced breast cancer: a multicenter, randomized, double-blind, parallel-controlled, phase III equivalence trial.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis randomized, double-blind study aimed to establish the equivalence of TQB2440 (a pertuzumab biosimilar) versus the reference pertuzumab, in the combination of trastuzumab and docetaxel, for patients with human epidermal growth factor receptor 2 (HER2)-positive early or locally advanced breast cancer. MATERIALS AND
methodsPatients were randomly assigned (1 : 1) to receive four cycles of neoadjuvant therapy, either TQB2440 or the reference pertuzumab each plus trastuzumab and docetaxel, followed by surgery and adjuvant treatment. The primary endpoint was total pathological complete response (tpCR) by an independent review committee (IRC), with equivalence margins of 0.76-1.32. Secondary endpoints included breast pathological complete response (bpCR) by IRC, tpCR/bpCR by the investigator, breast-conserving surgery (BCS) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), and safety.
resultsFrom 21 October 2020 to 14 August 2022, 412 patients were assigned to TQB2440 (207 patients) or reference pertuzumab (205 patients). The IRC-assessed tpCR was 58.9% with TQB2440 and 58.1% with the reference pertuzumab. The relative risk was 1.02 (90% confidence interval 0.89-1.16), which was entirely within the predefined equivalence margins. The IRC-assessed bpCR (67.6% versus 63.9%), investigator-assessed tpCR (60.4% versus 58.1%), bpCR (65.7% versus 62.0%), BCS rate (13.0% versus 13.2%), and ORR (73.9% versus 67.3%) were comparable in the two groups. At the data cut-off, the median EFS and DFS were not reached. Safety, pharmacokinetics (PK), and immunogenicity profiles were similar between the two groups.
conclusionTQB2440 showed equivalent efficacy, comparable safety, PK, and immunogenicity profiles to reference pertuzumab in the neoadjuvant treatment of patients with HER2-positive early or locally advanced breast cancer.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.