Clinical trial · Interventional
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy
NCT00005800CI-TRIAL-00008128completedPhase 2ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose-Dense Chemotherapy
- description
- Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.
- interventionNames
- Biological: Filgrastim
- Drug: Docetaxel
- Drug: Doxorubicin
- Procedure: Surgery
Primary outcomes (1)
- measure
- Pathological Response Rate
- timeFrame
- 7 years
- description
- Evaluate the pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. Pathologic response is classified as either complete pathologic response or partial pathologic response based on the size of residual tumor after treatment (complete pathologic response if 0 cm, partial pathologic response if \>0 cm).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or pathologically confirmed stage III breast cancer * Clinical evidence of primary invasive breast tumor greater than 5 cm in dimension (T3) and no evidence of metastatic disease clinically or by staging studies including computed tomography (CT) scan of the chest, abdomen, and pelvis, and a bone scan * Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the breast with an erysipeloid edge due to embolization of the dermal lymphatics and pathologic evidence of dermal lymphatic invasion * No bilateral breast cancer unless synchronous * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Female Menopausal status: * Not specified Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT/SGPT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * If prior cardiac event or ischemia on electrocardiogram, must be cleared by cardiologist * LVEF at least 50% by resting MUGA * No severe cardiac dysfunction * No prior or concurrent angina pectoris, congestive heart failure, or major ventricular arrhythmias * No uncontrolled essential hypertension Other: * Not pregnant or nursing * Fertile patients must use effective nonhormonal barrier contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma in situ of the breast * No other serious medical or psychiatric illness that would preclude study consent or treatment * No prior severe and intolerable reactions to filgrastim (G-CSF) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the breast Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.