Clinical trial · Interventional
Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
Pilot Study to Evaluate the Effect of Sunitinib on Occult Tumor Cells in the Bone Marrow of Patients With High Risk Early Stage Breast Cancer
NCT00824538CI-TRIAL-00032379terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed prematurely due to emerging data on toxicity and competing trials.
Summary
Brief summary (as posted)
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.
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 |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sunitinib
- description
- Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
- interventionNames
- Drug: sunitinib malate
- Other: flow cytometry
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
- timeFrame
- Baseline, 6 months after start of treatment
- description
- DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed high-risk breast cancer * Stage I-III disease * Has undergone definitive surgery with or without radiotherapy * Completely resected disease * Bone marrow aspirate positive for occult tumor cells, defined as ≥ 10 occult tumor cells/mL by IHC and flow cytometry * If the patient received either no adjuvant therapy or hormonal therapy alone, the aspiration may have been performed at diagnosis as part of the large micrometastasis study at UCSF, or following diagnosis if the patient underwent initial surgery elsewhere (or underwent surgery following neoadjuvant therapy for breast cancer) * If the patient received adjuvant chemotherapy, the aspiration must have been performed ≥ 3 weeks after completion of chemotherapy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-1 * WBC count normal (3.4-10 x 10\^9/L) * Hemoglobin \> 9.0 g/dL * Platelet count normal (140-450 x 10\^9/L) * ANC normal (1.8-6.8 x 10\^9/L) * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * TSH and T4 levels normal * LVEF \> 50% * Systolic BP \< 140 mm Hg and diastolic BP \< 90 mm Hg * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of HIV infection * No concurrent severe illness that would likely preclude study compliance * No other malignancy within the past 5 years except basal cell carcinoma of the skin PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior sunitinib malate * Prior adjuvant chemotherapy, including trastuzumab (Herceptin®), allowed provided it was completed within the past 6 months * Prior surgery following neoadjuvant chemotherapy or hormonal therapy allowed * No concurrent potent CYP3A4 inducers * No concurrent trastuzumab * Concurrent hormonal therapy or radiotherapy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.