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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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
sunitinib malate
flow cytometry
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    sunitinib

    Arm 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

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
    DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL

    Secondary Outcome Measures

    Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study
    Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
    Relapse-free and Overall Survival
    Data was not collected due to emerging data on toxicity and competing trials.
    Effect of Sunitinib Malate on OTC in Peripheral Blood
    Data was not collected due to emerging data on toxicity and competing trials.

    Full Information

    First Posted
    January 15, 2009
    Last Updated
    March 9, 2018
    Sponsor
    University of California, San Francisco
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00824538
    Brief Title
    Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Closed prematurely due to emerging data on toxicity and competing trials.
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    November 10, 2010 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sunitinib
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    sunitinib malate
    Intervention Type
    Other
    Intervention Name(s)
    flow cytometry
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
    Description
    DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
    Time Frame
    Baseline, 6 months after start of treatment
    Secondary Outcome Measure Information:
    Title
    Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study
    Time Frame
    after 6 months from start of treatment
    Title
    Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
    Time Frame
    up to 7 months after start of treatment
    Title
    Relapse-free and Overall Survival
    Description
    Data was not collected due to emerging data on toxicity and competing trials.
    Time Frame
    up to 3 years from beginning of treatment
    Title
    Effect of Sunitinib Malate on OTC in Peripheral Blood
    Description
    Data was not collected due to emerging data on toxicity and competing trials.
    Time Frame
    After one year of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hope S. Rugo, MD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow

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