Trial reportBreast cancer research and treatment2013
Randomized trial of preoperative docetaxel with or without capecitabine after 4 cycles of 5-fluorouracil– epirubicin–cyclophosphamide (FEC) in early-stage breast cancer: exploratory analyses identify Ki67 as a predictive biomarker for response to neoadjuvant chemotherapy.
Trial report in Breast cancer research and treatment, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 5 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
31 citing papers in PubMed, 5 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer.The Cochrane database of systematic reviews · 2021Pooled it
- Pooled it
- Pooled it
- Pooled it
- Pooled it
- Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Trial
- Proliferative Markers in Breast Cancer and Chemotherapy Implications: A Comprehensive Review.Health science reports · 2025Article
- TP53 signature predicts pathological complete response after neoadjuvant chemotherapy for breast cancer: Observational and confirmational study using prospective study cohorts.Translational oncology · 2024Article
- Treatment landscape of triple-negative breast cancer - expanded options, evolving needs.Nature reviews. Clinical oncology · 2022Review
- Neoadjuvant Chemotherapy for Breast Cancer: Evolution of Clinical Practice in a French Cancer Center Over 16 Years and Pathologic Response Rates According to Tumor Subtypes and Clinical Tumor Size: Retrospective Cohort Study.Journal of surgery and research · 2022Article
- Clinical Significance of Breast Cancer Molecular Subtypes and Ki67 Expression as a Predictive Value for Pathological Complete Response following Neoadjuvant Chemotherapy: Experience from a Tertiary Care Center in Lebanon.International journal of breast cancer · 2022Article
- The Prognostic Value of Lymph Node Involvement after Neoadjuvant Chemotherapy Is Different among Breast Cancer Subtypes.Cancers · 2021Article
- Clinicopathological Features and Treatment Challenges in Triple Negative Breast Cancer Patients: A Retrospective Cohort Study.Turk patoloji dergisi · 2021Article
- A Pilot Study of Extended Adjuvant Therapy with Metronomic Docetaxel for Patients with Operable Triple-Negative Breast Cancer.Asian Pacific journal of cancer prevention : APJCP · 2020Article
- Role of Capecitabine in Early Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Article
- Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer: A Review.OncoTargets and therapy · 2020Review
- Post-neoadjuvant treatment and the management of residual disease in breast cancer: state of the art and perspectives.Therapeutic advances in medical oncology · 2019Review
- Addition of Capecitabine in Breast Cancer First-line Chemotherapy Improves Survival of Breast Cancer Patients.Journal of Cancer · 2019Article
- Tumor metabolism assessed by FDG-PET/CT and tumor proliferation assessed by genomic grade index to predict response to neoadjuvant chemotherapy in triple negative breast cancer.European journal of nuclear medicine and molecular imaging · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 19 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This randomized, multicenter study compared the efficacy of docetaxel with or without capecitabine following fluorouracil/epirubicin/cyclophosphamide (FEC) therapy in operable breast cancer and investigated the role of Ki67 as a predictive biomarker. Patients were randomized to 4 cycles of docetaxel/capecitabine (docetaxel: 75 mg/m2 on day 1; capecitabine: 1,650 mg/m2 on days 1–14 every 3 weeks) or docetaxel alone (75 mg/m2 on day 1 every 3 weeks) after completion of 4 cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). The primary endpoint was the pathological complete response (pCR) rate. Predictive factor analysis was conducted using clinicopathological markers, including hormone receptors and Ki67 labeling index (Ki67LI). A total of 477 patients were randomized; the overall response in the docetaxel/capecitabine and docetaxel groups was 88.3 and 87.4 %, respectively. There were no significant differences in the pCR rate (docetaxel/capecitabine: 23 %; docetaxel: 24 %; p = 0.748), disease-free survival, or overall survival. However, patients with mid-range Ki67LI (10–20 %) showed a trend towards improved pCR rate with docetaxel/capecitabine compared to docetaxel alone. Furthermore, multivariate logistic regression analysis showed pre-treatment Ki67LI (odds ratio 1.031; 95 % CI 1.014–1.048; p = 0.0004) to be a significant predictor of pCR in this neoadjuvant treatment setting. Docetaxel/capecitabine (after 4 cycles of FEC) did not generate significant improvement in pCR compared to docetaxel alone. However, exploratory analyses suggested that assessment of pre-treatment Ki67LI may be a useful tool in the identification of responders to preoperative docetaxel/capecitabine in early-stage breast cancer.
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.