Clinical trial · Interventional
Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epirubicin
- interventionNames
- Biological: pegfilgrastim
- Drug: epirubicin hydrochloride
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Complete pathological response rate by tumor analysis after surgery
- timeFrame
- 4 weeks
- description
- No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
Secondary outcomes (4)
- measure
- Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)
* Resectable disease
* Unidimensionally measurable disease
* Primary tumor ≥ 2 cm
* No known distant metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,500/mm\^3
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 100,000/mm\^3
* No known untreated bleeding diathesis
Hepatic
* AST ≤ 2 times upper limits of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization
Other
* Not pregnant or breastfeeding
* Fertile patients must use effective contraception
* Negative pregnancy test
* No concurrent illness that would preclude study treatment
* No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim (G-CSF), or any other component of these products
PRIOR CONCURRENT THERAPY: Not specifiedReferences
Publications (0)
Data not yet available