Clinical trial · Interventional
Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer
Phase I/II Study of SU11248 (Sutent) in Combination With Metronomic Dosing of Cyclophosphamide and Methotrexate in Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Risk to benefit ratio not acceptable
Summary
Brief summary (as posted)
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic 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 |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib, Cyclophosphamide, and Methotrexate
- interventionNames
- Drug: cyclophosphamide
- Drug: methotrexate
- Drug: sunitinib malate
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Maximum Tolerated Dose of Sunitinib (Phase I)
- timeFrame
- 8 weeks
- description
- Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature \> 38.5 degrees Celsius or 3 readings of oral temperature \> 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment. 5\) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed diagnosis of breast cancer with documented progressive disease * Metastatic disease * Measurable disease as defined by RECIST criteria or evaluable disease * Must have received at least one prior chemotherapy regimen for metastatic breast cancer * Patients refusing all other chemotherapy for breast cancer may enroll without prior treatment * Patients with HER2-overexpression disease must have been previously treated with trastuzumab (Herceptin®) * Patients with stable brain metastases are eligible * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute Neutrophil Count (ANC) ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases) * Total bilirubin ≤ 1.5 times ULN * Able to take oral medications and maintain hydration * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after treatment * No severe concurrent illness including, but not limited to, any of the following: * Congestive heart failure * Significant cardiac disease * Uncontrolled hypertension * Must be able to read and speak English PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior treatment, including chemotherapy, hormonal therapy, trastuzumab (Herceptin®), or other targeted therapies * Prior bevacizumab allowed if discontinued for any reason other than toxicity * No potent inducers or inhibitors of CYP3A4 enzymes that effect the metabolism of sunitinib malate * No prior sunitinib malate * No other concurrent investigational therapy * No concurrent radiotherapy * Concurrent bisphosphonates allowed
References
Publications (0)
Data not yet available