Clinical trial · Interventional
Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial
- 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if chemotherapy followed by peripheral stem cell transplantation is more effective than chemotherapy alone in treating metastatic breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV 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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| CMF regimen | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast carcinoma Bone metastasis as only form of metastatic disease allowed No evidence of bone marrow involvement by aspirate or biopsy No brain metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 59 Sex: Female Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL PT normal Activated PTT normal Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia is present) No AST/ALT greater than 1.5 times upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN No active hepatitis B or C Renal: Creatinine normal Cardiovascular: Ejection fraction normal by MUGA or echocardiogram No active heart disease No prior myocardial infarction or other manifestation of coronary artery disease Other: More than 1,000 calories/day oral intake HIV negative No active serious medical or psychiatric disease No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No allergy to polysorbate 80 or E. coli-derived products No peripheral neuropathy greater than grade 2 Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease No prior mitomycin, nitrosoureas, or platinum coordination complexes Prior adjuvant chemotherapy allowed if completed more than 6 months prior to relapse with metastases No more than 300 mg/m2 prior doxorubicin or 450 mg/m2 prior epirubicin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain or marrow-bearing pelvis Prior radiotherapy to lower pelvis allowed if the upper border of the radiotherapy field is below the upper border of the acetabulum No other prior radiotherapy to the pelvis Surgery: At least 2 weeks since prior major surgery Other: No other concurrent anti-cancer therapy
References
Publications (0)
Data not yet available