ArticleThe oncologist2025
Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials.
Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 1 paper.
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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.
Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration
Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients
Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients
Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients
Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.
Who cites it
1 citing paper in PubMed.
- Clinical value and cost-effectiveness analysis of conditionally approved anticancer drugs in China from 2015 to 2023.Translational cancer research · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
IMPORTANCE AND
objectiveSeveral definitions of efficacy endpoints have been proposed for clinical trials in early breast cancer (EBC). Invasive disease-free survival (IDFS) and other endpoints have been used as surrogates for overall survival (OS) in adjuvant trials. The aim was to evaluate these endpoints in a comparative way in a large cohort of patients to assess whether they are appropriate surrogates for OS. PARTICIPANTS AND
designIndividual patient data from 8 phase III randomized adjuvant chemotherapy (CT) trials for EBC were analyzed. Trial-level surrogacy analyses were conducted using weighted least squares regression to assess the association between treatment effects on surrogates at different time points-IDFS and other defined endpoints (by STEEP v2.0)-and OS. Correlation between the log hazard ratio (HR) of the endpoints and OS were quantified using R2 values. Preplanned subgroup analyses by tumor subtype were also performed.
resultsResults censoring at 5 years and at longer follow-up (median: 9.6 years) were similar. HR of IDFS and invasive BC-free survival (IBCFS) at 5 years showed a R2 > 0.7 relative to HR of OS. All other surrogates revealed correlations with R2 > 0.5. For patients with hormone receptor-positive/HER2-negative intermediate/high-risk tumors, correlation showed higher R2 for IDFS (R2 = 0.89; 95% confidence interval [CI] = [0.80-0.98]) and IBCFS (R2 = 0.84; 95% CI = [0.71-0.97]) than distant-recurrence endpoints, while for those with triple negative tumors the highest correlation was seen with distant disease-free survival (R2 = 0.86; 95% CI = [0.75-0.98]). CONCLUSIONS AND RELEVANCE: Although all studied endpoints are appropriate surrogates for OS when evaluating CT-based adjuvant interventions, investigators should consider the BC subtype to select the primary endpoint. Trial registration number: ClinTrials.gov: GEICAM/9805: NCT00121992; GEICAM/9906: NCT00129922; GEICAM/2003-02: NCT00129389; GEICAM/2003-10: NCT00129935; CIBOMA/2004-01_GEICAM/2003-11: NCT00130533; BCIRG 001: NCT00688740; BCIRG 005: NCT00312208 and BCIRG 006: NCT00021255.
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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.