Clinical trial · Observational
Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer
An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support
NCT02527317CI-TRIAL-00031625completedClinicalTrials.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)
This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipegfilgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- incidence of treatment-related neutropenia
- timeFrame
- four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
- description
- The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
Secondary outcomes (2)
- measure
- incidence of febrile neutropenia
- timeFrame
- four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
- description
- Determine the incidence of febrile neutropenia during 4 cycles (8 weeks) of dose dense AC with lipegfilgrastim
- measure
- incidence of treatment-related neutropenia
- timeFrame
- Up to 1 year of subsequent chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Stage I-III Breast Cancer 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below) 4. Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100 5. Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist General Indications for Dose Dense AC include: 1. T3 or T4 Tumours 2. N1 - N3 (Node Positive) Disease 3. Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours. 4. Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2 Exclusion Criteria: 1. Stage IV Breast Cancer 2. Pregnancy 3. Previous Chemotherapy Exposure 4. Prior Exposure to G-CSF 5. Known positive HIV Status 6. Cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of AC
References
Publications (0)
Data not yet available
No reference posted for this study.