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

NCT00824538 | Terminated Phase 2 Results DMC

• 1 other identifier: 077539
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 6 months after start of treatment

Secondary Outcomes (4)

• Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study

  after 6 months from start of treatment

• Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0

  up to 7 months after start of treatment

• Relapse-free and Overall Survival

  up to 3 years from beginning of treatment

• Effect of Sunitinib Malate on OTC in Peripheral Blood

  After one year of treatment

Study Arms (1)

sunitinib

EXPERIMENTAL

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

Drug: sunitinib malate; Other: flow cytometry; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Interventions

sunitinib malate DRUG

sunitinib

flow cytometry OTHER

sunitinib

immunohistochemistry staining method OTHER

sunitinib

laboratory biomarker analysis OTHER

sunitinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Flow Cytometry; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques

Limitations and Caveats

The study closed early due to results released from a phase III metastatic breast cancer (MBC) study that demonstrated significant sunitinib toxicity without commensurate clinical benefit.

Results Point of Contact

• Title: Hope S Rugo
• Organization: University of California San Francisco

clinicaltrials@ucsf.edu

877-827-3222

Study Officials

• Hope S. Rugo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: February 1, 2009
• Primary Completion: November 10, 2010
• Study Completion: December 1, 2013
• Last Updated: April 5, 2018
• Results First Posted: May 8, 2014

Record last verified: 2018-03