Trial reportCancer research and treatment2019
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).
Trial report in Cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 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
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Comparative efficacy of subsequent-line therapies for advanced triple-negative breast cancer: a bayesian network meta-analysis.Oncology reviews · 2026Pooled it
- A meta-analysis and systematic review of the first Trop-2-targeting antibody-drug conjugate (sacituzumab govitecan) in treating metastatic breast cancer.European journal of clinical pharmacology · 2025Pooled it
- Clinical management of adverse events in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine.The oncologist · 2026Trial
- Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors.International journal of clinical oncology · 2024Trial
- Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.Breast cancer research and treatment · 2022Trial
- Exploring trop-2-directed ADCs monotherapy and combination therapy in pretreated mTNBC: a real-world study.Breast cancer research and treatment · 2026Article
- Second-Line Treatment Options for Patients with Metastatic Triple-Negative Breast Cancer: A Review of the Clinical Evidence.Targeted oncology · 2025Review
- Partial Response Achieved in a Case of Metastatic Triple-Negative Breast Cancer Based on the Patient-Derived Tumor Organoids.International journal of women's health · 2025Article
- The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group.Cancer research and treatment · 2025Article
- Eribulin plus carboplatin combination for HER2-negative metastatic breast cancer: a multicenter, real-world cohort study.BMC cancer · 2024Article
- Synergizing Immunotherapy and Antibody-Drug Conjugates: New Horizons in Breast Cancer Therapy.Pharmaceutics · 2024Review
- Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.NPJ breast cancer · 2024Article
- Targeting EMSY-mediated methionine metabolism is a potential therapeutic strategy for triple-negative breast cancer.Cell reports. Medicine · 2024Article
- Challenges in HER2-low breast cancer identification, detection, and treatment.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2024Review
- Cost-effectiveness of sacituzumab govitecan versus chemotherapy in patients with relapsed or refractory metastatic triple-negative breast cancer.BMC health services research · 2023Article
- Update on Classic and Novel Approaches in Metastatic Triple-Negative Breast Cancer Treatment: A Comprehensive Review.Biomedicines · 2023Review
- Post-marketing safety surveillance of sacituzumab govitecan: an observational, pharmacovigilance study leveraging FAERS database.Frontiers in pharmacology · 2023Article
- Apatinib plus vinorelbine versus vinorelbine for metastatic triple-negative breast cancer who failed first/second-line treatment: the NAN trial.NPJ breast cancer · 2022Article
- Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer.NPJ breast cancer · 2022Article
- Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer-phase 3 ASCENT study subanalysis.NPJ breast cancer · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 9 institutions in 1 country.
Funding
Abstract
purposeWe investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). MATERIALS AND
methodsA total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS.
resultsThere was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea.
conclusionIrinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.
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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.