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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of sunitinib malate on occult tumor cells (OTC) in bone marrow

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Hope S. Rugo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms