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Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), January 2009
First Received: January 15, 2009   Last Updated: February 5, 2009   History of Changes
Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00824538
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: sunitinib malate
Other: flow cytometry
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effect of sunitinib malate on occult tumor cells (OTC) in bone marrow [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients who are able to tolerate sunitinib malate for 6 months and complete the study [ Designated as safety issue: Yes ]
  • Toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Effect of sunitinib malate on OTC in peripheral blood [ Designated as safety issue: No ]
  • Correlative markers, including endothelial cells, soluble cKIT, and VEGF [ Designated as safety issue: No ]
  • Relapse-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the effect of sunitinib malate on occult tumor cells (OTC) in the bone marrow of patients with high-risk stage I-III breast cancer.

Secondary

  • To evaluate the number of patients who are able to tolerate this drug for 6 months and complete the study.
  • To evaluate the toxicities of this drug in these patients.
  • To evaluate the effects of this drug on OTC in peripheral blood.
  • To evaluate correlative markers, including endothelial cells, soluble cKIT, and VEGF.
  • To evaluate relapse-free and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral sunitinib malate once daily for 6 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and peripheral blood sample collection at baseline and at 6 and 12 months. Bone marrow aspirate samples are analyzed by IHC and flow cytometry. Peripheral blood samples are analyzed for circulating tumor cells.

After completion of study treatment, patients are followed at 1 and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824538

Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Principal Investigator: Hope S. Rugo, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UCSF Helen Diller Family Comprehensive Cancer Center ( Hope S. Rugo )
Study ID Numbers: CDR0000632345, UCSF-077539
Study First Received: January 15, 2009
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00824538     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Skin Diseases
Sunitinib
Breast Neoplasms
Angiogenesis Inhibitors
Breast Diseases

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009