Trial reportClinical breast cancer2016
N0436 (Alliance): A Phase II Trial of Irinotecan With Cetuximab in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane-Containing Therapy.
Trial report in Clinical breast cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
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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
29 citing papers in PubMed, 56 citations in OpenAlex.
- [Breast cancer research : BCR · 2026Article
- Review
- Integrating traditional biomarkers and emerging predictors to assess neoadjuvant chemotherapy efficacy in breast cancer: a multifactorial analysis of Ki-67, CDK4, EGFR, TILs and ctDNA.BMC women's health · 2024Article
- Breast cancer therapy: from the perspective of glucose metabolism and glycosylation.Molecular biology reports · 2024Review
- A Stable Irinotecan Liposome with Enhanced Antitumor Activity in a Range of Tumor Models.Pharmaceutical research · 2023Article
- Article
- Surface roughness modulates EGFR signaling and stemness of triple-negative breast cancer cells.Frontiers in cell and developmental biology · 2023Article
- Review
- Beyond HER2: Targeting the ErbB receptor family in breast cancer.Cancer treatment reviews · 2022Review
- Nanocarriers: A Reliable Tool for the Delivery of Anticancer Drugs.Pharmaceutics · 2022Review
- Review
- Potentiating Therapeutic Effects of Epidermal Growth Factor Receptor Inhibition in Triple-Negative Breast Cancer.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Standard of Care and Promising New Agents for the Treatment of Mesenchymal Triple-Negative Breast Cancer.Cancers · 2021Review
- Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase.Breast cancer research and treatment · 2021Article
- A Retrospective Analysis of the Effect of Irinotecan-Based Regimens in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes.Frontiers in oncology · 2021Article
- Cetuximab and IL-15 Promote NK and Dendritic Cell Activation In Vitro in Triple Negative Breast Cancer.Cells · 2020Article
- Article
- EGFR-targeted CAR-T cells are potent and specific in suppressing triple-negative breast cancer bothClinical & translational immunology · 2020Article
- Molecular subtypes and precision treatment of triple-negative breast cancer.Annals of translational medicine · 2020Review
- Polymeric Nanocarriers of Drug Delivery Systems in Cancer Therapy.Pharmaceutics · 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
7 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundIrinotecan has a 20% to 25% response rate (RR) in patients with previously treated metastatic breast cancer (MBC). Epidermal growth factor receptor (EGFR) is overexpressed in some MBC, especially in triple-negative breast cancer (TNBC). Cetuximab is a monoclonal antibody against EGFR with additive preclinical activity with irinotecan. PATIENTS AND
methodsWe report a 1-stage phase II study on MBC, measurable disease, and previous anthracycline and/or taxane therapy. Patients received cetuximab 400 mg/m(2) on day 1 cycle 1 then 250 mg/m(2) weekly thereafter and irinotecan 80 mg/m(2) on days 1 and 8 of each 21-day cycle. The primary end point was overall RR (ORR) according to Response Evaluation Criteria in Solid Tumors criteria (version 1.1).
resultsOf 19 eligible patients enrolled from February to September 2006, 14 patients (74%) had visceral disease, seven patients (37%) were hormone receptor-positive, two patients (11%) HER2-positive, and 11 patients (58%) were triple-negative. Patients received a median of 2 cycles (range, 1-37). Confirmed ORR was 11% (95% confidence interval [CI], 1%-33%), with 1 partial response and 1 complete response. One patient had stable disease for 8 months. RR for TNBC versus non-TNBC was 18% versus 0% (P = .49). Median time to progression was 1.4 months (95% CI, 1.0-2.2) and median overall survival was 9.4 months (95% CI, 2.8-16.1). Twelve patients had disease progression within 2 cycles during therapy. Because of a low RR and rapid disease progression, the study leadership decided to close the trial early.
conclusionThe tolerability of the combination of cetuximab and irinotecan is acceptable but demonstrated low overall activity. Potentially promising results were noted in patients with TNBC and further studies of these patients might be considered.
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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.