Clinical trial · Observational
Pooled Analysis of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy: a Hellenic Cooperative Oncology Group (HeCOG) Study.
Pooled Analysis of Individual Patient Data of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy (Ddsc): a Hellenic Cooperative Oncology Group (HeCOG) Study
NCT07521397CI-TRIAL-00107681ΗE_10R/22completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to assess survival outcomes and treatment-related toxicity in patients with early-stage breast cancer receiving adjuvant therapies, using high-quality individual patient data pooled from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG), including 3 phase III trials and 4 observational studies. This study aims to assess long-term disease-free survival (DFS) and overall survival (OS), as well as the toxicity patterns associated with dose-dense sequential chemotherapy in intermediate or high-rsk patients.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Overall Survival | — | UNRESOLVED | — |
| Prognosis Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Early Breast Cancer Cohort
- description
- Patients with early-stage breast cancer included in pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). Patients received adjuvant treatment.
Primary outcomes (1)
- measure
- Disease-Free Survival
- timeFrame
- From date of diagnosis or surgery to first documented recurrence or death.
- description
- Disease-Free survival is defined as the time from diagnosis or surgery to the first documented recurrence of breast cancer (local, regional, or distant) or death from any cause. Patients without an event are censored at the last follow-up.
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- From date of diagnosis or surgery to death from any cause. Patients alive at last follow-up are censored at that date
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with early-stage, surgically resected breast cancer (high or intermediate risk), randomized to receive adjuvant or neoadjuvant dose-dense sequential chemotherapy. Exclusion Criteria: * Patients with metastatic or locally advanced breast cancer at initial diagnosis. Patients who did not receive dose-dense sequential chemotherapy.
References
Publications (15)
- BACKGROUNDBreast Cancer. NCCN clinical practice guideline in Oncology.https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- BACKGROUNDFountzilas G, Dafni U, Papadimitriou C, Timotheadou E, Gogas H, Eleftheraki AG, Xanthakis I, Christodoulou C, Koutras A, Papandreou CN, Papakostas P, Miliaras S, Markopoulos C, Dimitrakakis C, Korantzopoulos P, Karanikiotis C, Bafaloukos D, Kosmidis P, Samantas E, Varthalitis I, Pavlidis N, Pectasides D, Dimopoulos MA. Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial. BMC Cancer. 2014 Jul 15;14:515. doi: 10.1186/1471-2407-14-515. PMID 25026897
- BACKGROUNDPapadimitriou CA, Papakostas P, Timotheadou E, Aravantinos G, Bamias A, Fountzilas G. Adjuvant dose-dense sequential chemotherapy with epirubicin, CMF and weekly paclitaxel in patients with resected high-risk breast cancer: a Hellenic Cooperative Oncology Group (HeCOG) study. Cancer Invest. 2008 Jun;26(5):491-8. doi: 10.1080/07357900701829785. PMID 18568771
- BACKGROUNDFountzilas G, Pectasides D, Christodoulou C, Timotheadou E, Economopoulos T, Papakostas P, Papadimitriou C, Gogas H, Efstratiou I, Skarlos D. Adjuvant dose-dense sequential chemotherapy with epirubicin, CMF, and weekly docetaxel is feasible and safe in patients with operable breast cancer. Med Oncol. 2006;23(4):479-88. doi: 10.1385/MO:23:4:479. PMID 17303906
- BACKGROUNDGogas H, Dafni U, Karina M, Papadimitriou C, Batistatou A, Bobos M, Kalofonos HP, Eleftheraki AG, Timotheadou E, Bafaloukos D, Christodoulou C, Markopoulos C, Briasoulis E, Papakostas P, Samantas E, Kosmidis P, Stathopoulos GP, Karanikiotis C, Pectasides D, Dimopoulos MA, Fountzilas G. Postoperative dose-dense sequential versus concomitant administration of epirubicin and paclitaxel in patients with node-positive breast cancer: 5-year results of the Hellenic Cooperative Oncology Group HE 10/00 phase III Trial. Breast Cancer Res Treat. 2012 Apr;132(2):609-19. doi: 10.1007/s10549-011-1913-4. Epub 2011 Dec 21.