Trial reportInvestigational new drugs2013
Phase II study of irinotecan plus capecitabine in anthracycline- and taxane- pretreated patients with metastatic breast cancer.
Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed, 15 citations in OpenAlex.
- Randomized Open Label Phase III Trial of Irinotecan Plus Capecitabine versus Capecitabine Monotherapy in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane: PROCEED Trial (KCSG BR 11-01).Cancer research and treatment · 2019Trial
- Efficacy and safety of eribulin plus gemcitabine as second-line treatment for recurrent HER2-negative breast cancer: a phase II, single-arm, open-label trial.Communications medicine · 2026Article
- 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
- Chemotherapy Options beyond the First Line in HER-Negative Metastatic Breast Cancer.Journal of oncology · 2020Review
- A meta-analysis of combination therapy versus single-agent therapy in anthracycline- and taxane-pretreated metastatic breast cancer: results from nine randomized Phase III trials.OncoTargets and therapy · 2016Article
- Molecular insights into microbial β-glucuronidase inhibition to abrogate CPT-11 toxicity.Molecular pharmacology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To evaluate the efficacy and tolerability of combined treatment with irinotecan (I) and capecitabine (X), we conducted a phase II study of the IX combination in anthracycline- and taxane-pretreated patients with metastatic breast cancer (MBC). Patients received 80 mg/m(2) I on days 1 and 8 and 1,000 mg/m(2) X twice daily on days 1-14 of 21-day cycles until disease progression. The primary endpoint was the objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Thirty-six patients were enrolled between September 2006 and April 2008. The median follow-up was 47.6 months. The ORR was 58.3 % (95 % CI, 42.2-72.9), with 3 complete responses and 18 partial responses. The median PFS was 7.6 months (95 % CI, 5.0-10.2), and the median OS was 20.0 months (95 % CI, 11.6-28.4). Neutropenia was the most common adverse event (grade 3, 30.6 %; grade 4, 27.8 %) with febrile neutropenia in 2 patients (5.6 %). Three patients (8.3 %) had grade 3 diarrhea, 3 patients (8.3 %) had grade 3 asthenia, and 1 patient (2.8 %) had grade 3 hand-foot syndrome. The IX combination was effective and tolerable for anthracycline- and taxane-pretreated patients with MBC. A phase III trial of this combination is ongoing.
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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.