Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012
Six cycles of doxorubicin and cyclophosphamide or Paclitaxel are not superior to four cycles as adjuvant chemotherapy for breast cancer in women with zero to three positive axillary nodes: Cancer and Leukemia Group B 40101.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00041119 (Cyclophosphamide And Doxorubicin), which is not on this map. Cited by 40 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.
Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
Who cites it
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.
- Taxanes for adjuvant treatment of early breast cancer.The Cochrane database of systematic reviews · 2019Pooled it
- Breast cancer follow-up strategies in randomized phase III adjuvant clinical trials: a systematic review.Journal of experimental & clinical cancer research : CR · 2013Pooled it
- Long-term follow-up of S0221, comparing alternative dose-schedules of anthracycline and taxane therapy in early breast cancer.JNCI cancer spectrum · 2026Trial
- Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Age and the Risk of Paclitaxel-Induced Neuropathy in Women with Early-Stage Breast Cancer (Alliance A151411): Results from 1,881 Patients from Cancer and Leukemia Group B (CALGB) 40101.The oncologist · 2019Trial
- Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Trial
- SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Trial
- Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance).The pharmacogenomics journal · 2014Trial
- Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Trial
- A genome-wide association study identifies novel loci for paclitaxel-induced sensory peripheral neuropathy in CALGB 40101.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Trial
- Comparison of chemotherapeutic combination therapy, dosing frequency and dosing sequence for the adjuvant treatment of early-stage breast cancer: a network meta-analysis.Annals of medicine · 2026Article
- An economic analysis of Chemo MouthpieceJournal of comparative effectiveness research · 2026Article
- Adaptive Bayesian Clinical Trials: The Past, Present, and Future of Clinical Research.Journal of clinical medicine · 2025Article
- Transporting: What Is It and How Do You Do It?Current epidemiology reports · 2025Article
- Detection of circulating tumour cells before and following adjuvant chemotherapy and long-term prognosis of early breast cancer.British journal of cancer · 2022Article
- De-escalation of adjuvant chemotherapy for HER2 negative breast cancer.The Lancet regional health. Western Pacific · 2021Article
- PROGNOSTIC VALUE OF TOPOISOMERASE 2-ALPHA AND B-MYB IN EARLY BREAST CANCER TREATED WITH ADJUVANT CHEMOTHERAPY.Acta clinica Croatica · 2021Article
- Established and Validated Novel Nomogram for Predicting Prognosis of Post-Mastectomy pN0-1 Breast Cancer without Adjuvant Radiotherapy.Cancer management and research · 2021Article
- Older-Patient-Specific Cancer Trials: A Pooled Analysis of 2,277 Patients (A151715).The oncologist · 2019Article
- Adjuvant Anthracyclines in Breast Cancer: What Is Their Role?The oncologist · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 1 institution in 1 country.
Funding
Abstract
purposeThe ideal duration of adjuvant chemotherapy for patients with lower risk primary breast cancer is not known. Cancer and Leukemia Group B trial 40101 was conducted using a phase III factorial design to define whether six cycles of a chemotherapy regimen are superior to four cycles. We also sought to determine whether paclitaxel (T) is as efficacious as doxorubicin/cyclophosphamide (AC), but with reduced toxicity. PATIENTS AND
methodsBetween 2002 and 2008, the study enrolled women with operable breast cancer and zero to three positive nodes. Patients were randomly assigned to either four or six cycles of either AC or T. Study stratifiers were estrogen receptor/progesterone receptor (ER/PgR), human epidermal growth factor receptor 2 (HER2), and menopausal status. After 2003, all treatment was administered in dose-dense fashion. The primary efficacy end point was relapse-free survival (RFS).
resultsA total of 3,171 patients were enrolled; 94% were node-negative and 6% had one to three positive nodes. At a median follow-up of 5.3 years, the 4-year RFS was 90.9% and 91.8% for six and four cycles, respectively. The adjusted hazard ratio (HR) of six to four cycles regarding RFS was 1.03 (95% CI, 0.84 to 1.28; P=.77). The 4-year OS was 95.3% and 96.3% for six and four cycles, respectively, with an HR of six to four cycles of 1.12 (95% CI, 0.84 to 1.49; P=.44). There was no interaction between treatment duration and chemotherapy regimen, ER/PgR, or HER2 status on RFS or OS.
conclusionFor women with resected primary breast cancer and zero to three positive nodes, we found no evidence that extending chemotherapy regimens of AC or single-agent T from four to six cycles improves clinical outcome.
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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.