Breast CancerPhase 2NCT00824538
Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
A Phase 2 study testing sunitinib malate, flow cytometry and immunohistochemistry staining method in people with Breast Cancer, run by University of California, San Francisco.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- sunitinib malate, flow cytometry and immunohistochemistry staining method
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- sunitinib malate, flow cytometry, immunohistochemistry staining method, laboratory biomarker analysis
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
flow cytometryOther
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: sunitinib malate; Other: flow cytometry; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: after 6 months from start of treatment
Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
Measured: up to 7 months after start of treatment
Relapse-free and Overall Survival
Data was not collected due to emerging data on toxicity and competing trials.
Measured: up to 3 years from beginning of treatment
Effect of Sunitinib Malate on OTC in Peripheral Blood
Data was not collected due to emerging data on toxicity and competing trials.
Measured: After one year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completion10 Nov 2010
- Study completionDec 2013
Why it stopped: Closed prematurely due to emerging data on toxicity and competing trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hope S. Rugo, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824538
- Sponsor's protocol ID
- 077539
- Other IDs
- 077539
- Status last verified
- Mar 2018
- First submitted
- 15 Jan 2009
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00824538
- Acronym / sponsor ID
- 077539
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed prematurely due to emerging data on toxicity and competing trials.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- 10 Nov 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib | Experimental | Drug: sunitinib malate, Other: flow cytometry, Other: immunohistochemistry staining method, Other: laboratory biomarker analysisStudy 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib malate | Drug | sunitinib |
| flow cytometry | Other | sunitinib |
| immunohistochemistry staining method | Other | sunitinib |
| laboratory biomarker analysis | Other | sunitinib |
Primary outcome
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
Time frame: Baseline, 6 months after start of treatment
DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
4 secondary outcomes
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
Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
Time frame: up to 7 months after start of treatment
Relapse-free and Overall Survival
Time frame: up to 3 years from beginning of treatment
Effect of Sunitinib Malate on OTC in Peripheral Blood
Time frame: After one year of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hope S. Rugo, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib malate, flow cytometry and immunohistochemistry staining method in people with Breast Cancer, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow (time frame: Baseline, 6 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.