Trial reportClinical breast cancer2015
Phase II Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2-Negative Breast Cancer.
Trial report in Clinical breast cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00877500 (A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-Negative Breast Cancer), which is not on this map. Cited by 12 papers.
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.
A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-Negative Breast Cancer
Who cites it
12 citing papers in PubMed, 18 citations in OpenAlex.
- Treatment Strategies for Residual Disease following Neoadjuvant Chemotherapy in Patients with Early-Stage Breast Cancer.Current oncology (Toronto, Ont.) · 2022Review
- Breast Cancer Treatments: Updates and New Challenges.Journal of personalized medicine · 2021Review
- Integrating Adjuvant Radiation with Post-Neoadjuvant Therapies in Early Breast Cancer.Current oncology reports · 2021Review
- Position of Circulating Tumor Cells in the Clinical Routine in Prostate Cancer and Breast Cancer Patients.Cancers · 2020Review
- Article
- Adjuvant chemotherapy for breast cancer after preoperative chemotherapy: A propensity score matched analysis.PloS one · 2020Article
- Post-neoadjuvant treatment and the management of residual disease in breast cancer: state of the art and perspectives.Therapeutic advances in medical oncology · 2019Review
- A Population of Heterogeneous Breast Cancer Patient-Derived Xenografts Demonstrate Broad Activity of PARP Inhibitor in BRCA1/2 Wild-Type Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Adding Adjuvant Systemic Treatment after Neoadjuvant Therapy in Breast Cancer: Review of the Data.Current oncology reports · 2017Review
- Chemotherapy reaction induced by ixabepilone, a microtubule stabilizing agent, mimicking extramammary Paget's disease in a patient with breast carcinoma.Journal of cutaneous pathology · 2016Article
- Epothilone B induces apoptosis and enhances apoptotic effects of ABT-737 on human cancer cells via PI3K/AKT/mTOR pathway.Journal of cancer research and clinical oncology · 2016Article
- Phenotype of circulating tumor cell: face-off between epithelial and mesenchymal masks.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
backgroundResidual disease (RD) after neoadjuvant chemotherapy carries an increased risk for recurrence. Ixabepilone has activity in anthracycline/taxanes-resistant breast cancer. We explored adjuvant ixabepilone in patients with significant RD HER2-negative breast cancer.
methodsA phase II study in patients with residual cancer burden II or III randomized to ixabepilone versus observation was conducted. Circulating tumor cells (CTCs) were measured at baseline and at 9 and 18 weeks. Survival probabilities were estimated by Kaplan-Meier product limit. Toxicities were reported as proportions in the ixabepilone arm.
resultsAccrual was stopped because of ixabepilone toxicity. Sixty-seven patients were registered; 43 were randomized, 19 received ixabepilone, and 24 went to observation. One patient (9.1%) in the observation arm versus 2 patients (18.2%) in the ixabepilone arm had CTCs at 18 weeks (P = 1.0). Three-year recurrence-free survival and overall survival were 94% and 82%, and 100% and 79% in the observation and ixabepilone arms (P = .35 and .18), respectively. Most common adverse events (AEs) included fatigue, pain, neuropathy, constipation, nausea, rash, anorexia, and diarrhea. Serious AEs included pain (63.2%), fatigue (31.6%), and neuropathy (31.6%).
conclusionsAdjuvant ixabepilone in patients with significant RD after neoadjuvant chemotherapy was difficult to administer because of AEs and did not change the presence of CTC or affect survival outcomes. NCT00877500.
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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.