Clinical trial · Interventional
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
NCT00003042CI-TRIAL-00103766completedPhase 2Results postedClinicalTrials.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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| mesna | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1 cycle of neoadjuvant chemotherapy
- description
- Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
- interventionNames
- Biological: filgrastim
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: melphalan
- Drug: mesna
- Drug: paclitaxel
- Drug: tamoxifen citrate
- Procedure: bone marrow ablation with stem cell support
- Procedure: conventional surgery
- Procedure: peripheral blood stem cell transplantation
- type
- EXPERIMENTAL
- label
- More than 1 cycle of neoadjuvant chemotherapy
- description
- Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin * Diagnosis within the past 6 months PATIENT CHARACTERISTICS: Age: * 60 and under Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT or SGPT no greater than 1.5 times the upper limit of normal Renal: * Creatinine less than 1.2 mg/dL * Creatinine clearance at least 80 mL/min * No history of hemorrhagic cystitis Cardiovascular: * Left ventricular fraction at least 55% on MUGA scan * No previous valvular heart disease or arrhythmia Pulmonary: * FEV\_1 at least 60% predicted * Room air pO\_2 greater than 85 mmHg * Room air pCO\_2 no greater than 43 mmHg * DLCO at least 60% of the lower limit of predicted value Other: * No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer * No organic CNS dysfunction * Not pregnant * No known and potentially disabling psychosocial history * Not positive for hepatitis B or HIV PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Stratum 1: * No more than one cycle of chemotherapy * Stratum 2: * No greater than 225 mg/m\^2 doxorubicin and no greater than 250 mg/m\^2 paclitaxel during previous chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiation to the left chest wall Surgery: * Modified radical mastectomy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.