Clinical trial · Interventional
Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early 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 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: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary breast cancer that is potentially operable
* Synchronous bilateral tumors eligible
* At least 3 cm in maximum diameter
* Tumors at least 2 cm eligible provided primary chemotherapy is deemed appropriate and radical surgery would otherwise be required
* No evidence of metastatic disease
* No prior breast cancer
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Transaminases no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No uncontrolled angina pectoris
* No heart failure
* No clinically significant uncontrolled cardiac arrhythmias
* LVEF at least 50%
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No medical or psychiatric condition that impairs ability to cope physically or psychologically with the chemotherapy regimen
* No other serious uncontrolled medical condition
* No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available