Trial reportCancer2020
Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer.
Trial report in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Health-related quality of life in Her2-positive early breast cancer woman using trastuzumab: A systematic review and meta-analysis.Frontiers in pharmacology · 2023Pooled it
- A Canadian national guideline on the neoadjuvant treatment of invasive breast cancer, including patient assessment, systemic therapy, and local management principles.Breast cancer research and treatment · 2022Guideline
- Trial
- Delayed Bleeding With Variable Presentations in Implant-Based Breast Reconstruction During Adjuvant Ado-Trastuzumab Emtansine (Kadcyla) Therapy: Two Case Reports.Journal of breast cancer · 2026Article
- Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer.Breast cancer research : BCR · 2026Review
- Patient-reported symptom burden and circulating cytokines undergoing chemotherapy: a pilot study in patients with ovarian cancer.Journal of gynecologic oncology · 2025Article
- Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Review
- Antibody-drug conjugates in breast cancer treatment: resistance mechanisms and the role of therapeutic sequencing.Cancer drug resistance (Alhambra, Calif.) · 2025Review
- Review
- Improved Survival of Young Patients With Breast Cancer 40 Years and Younger at Diagnosis.JCO global oncology · 2023Review
- The Global Landscape on the Access to Cancer Medicines for Breast Cancer: The ONCOLLEGE Experience.Cancer treatment and research · 2023Article
- Pathologic complete response and survival after neoadjuvant chemotherapy in cT1-T2/N0 HER2+ breast cancer.NPJ breast cancer · 2022Article
- Management of HER2-Positive Early Breast Cancer in Italy: A Maze Presenting Opportunities and Challenges.Frontiers in oncology · 2022Review
- Trastuzumab Emtansine: A Review of Its Adjuvant Use in Residual Invasive HER2-Positive Early Breast Cancer.Drugs · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 18 institutions in 10 countries.
Funding
Abstract
backgroundThe phase 3 KATHERINE trial demonstrated significantly improved invasive disease-free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy.
methodsPatients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30 days after study drug completion, and at 6- and 12-month follow-up visits.
resultsOf patients who were randomly assigned to T-DM1 (n = 743) and trastuzumab (n = 743), 612 (82%) and 640 (86%), respectively, had valid baseline and ≥1 postbaseline assessments. No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%).
conclusionThese data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.