Breast CancerNCT00436709
Bevacizumab, Doxorubicin, and Cyclophosphamide Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients Who Have Undergone Surgery for Early-Stage Breast Cancer
A study testing bevacizumab, pegfilgrastim and cyclophosphamide in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bevacizumab, pegfilgrastim and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer meeting the following criteria:
- Early-stage disease
- No stage IV disease
- More than one synchronous primary breast tumor
- Lymph node positive OR high-risk lymph node negative
- Candidate for treatment with anthracycline- and taxane-based chemotherapy in the adjuvant setting
- Must begin therapy within 84 days after the final required surgical procedure
- HER2/neu-negative breast cancer, defined as an immunohistochemistry (IHC) score of 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) not amplified
- No CNS disease (e.g., primary brain tumor or brain metastasis)
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Male or female
- Pre- or post-menopausal
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein:creatinine ratio ≤ 1.0
- PT and PTT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- LVEF normal by MUGA scan at baseline
- No significant bleeding within the past 6 months
- No uncontrolled underlying bleeding diathesis
- No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy, including any of the following conditions:
- Blood pressure > 150/100 mm Hg
- Unstable angina
- New York Heart Association class II -IV congestive heart failure
- Myocardial infarction or stroke within the past 12 months
- Clinically significant peripheral vascular disease
- No seizures not controlled with standard medical therapy
- No history of stroke
- No known allergy or hypersensitivity to study drugs (prior hypersensitivity to paclitaxel allowed)
- No significant traumatic injury within the past 28 days
- No serious nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No active gastroduodenal ulcer
- No uncontrolled intercurrent illness, including psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior therapy for an ipsilateral or contralateral breast cancer primary allowed provided the following criteria are met:
- No prior anthracycline therapy
- Prior hormonal therapy for this previous breast cancer is allowed, but must be stopped during study therapy
- At least 1 year since prior taxane therapy
- More than 28 days since prior and no concurrent major surgery or open biopsy
- Anticipated reconstructive surgery (e.g., tissue expander exchange) is allowed during the course of the study (bevacizumab will be held during that time as per protocol guidelines)
- More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsy
- At least 24 hours since prior indwelling catheter placement
- No prior bevacizumab or other KDR inhibitors (e.g., VEGF Trap, semaxanib, SU6668, vandetanib, vatalanib, AEE788, or IMC-1CII)
- No concurrent full-dose anticoagulation therapy
- No concurrent hormonal therapy as chemoprevention
- Concurrent participation in adjuvant hormone therapy or correlative or companion (e.g., bisphosphonate clinic) studies allowed
- No other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer.
Secondary
- Determine the noncardiac toxicity of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of time to tumor recurrence and overall survival, in these patients.
- Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease.
- Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen.
- Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy.
OUTLINE: This is a nonrandomized, pilot, multicenter study.
Patients receive doxorubicin hydrochloride IV, cyclophophamide IV, and bevacizumab IV over 30-90 minutes on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and pegfilgrastim SC on day 2. Treatment with paclitaxel albumin-stabilized nanoparticle formulation and pegfilgrastim repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1. Treatment with maintenance therapy repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study treatment. Samples are analyzed for circulating endothelial cells (by flow cytomery [FC]), circulating epithelial cells (by immunocytochemistry and FC), troponin I concentrations (by enzyme immunoassay or chemiluminescent microparticle immunoassay), and plasma renin activity (by radioimmunoassay).
After completion of study treatment, patients are followed every 4-6 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- bevacizumab, pegfilgrastim, cyclophosphamide, doxorubicin hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation
- Keywords
- male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
pegfilgrastimBiological
cyclophosphamideDrug
paclitaxel albumin-stabilized nanoparticle formulationDrug
flow cytometryOther
immunoenzyme techniqueOther
immunologic techniqueOther
laboratory biomarker analysisOther
adjuvant therapyProcedure or surgery
immunoscintigraphyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (3)
Noncardiac toxicity
Time to tumor recurrence
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Maura N. Dickler, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436709
- Sponsor's protocol ID
- CDR0000529855
- Other IDs
- MSKCC-06019
- Status last verified
- Jun 2007
- First submitted
- 15 Feb 2007
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00436709
- Acronym / sponsor ID
- CDR0000529855
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2006
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer.
Secondary
- Determine the noncardiac toxicity of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of time to tumor recurrence and overall survival, in these patients.
- Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease.
- Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen.
- Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy.
OUTLINE: This is a nonrandomized, pilot, multicenter study.
Patients receive doxorubicin hydrochloride IV, cyclophophamide IV, and bevacizumab IV over 30-90 minutes on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and pegfilgrastim SC on day 2. Treatment with paclitaxel albumin-stabilized nanoparticle formulation and pegfilgrastim repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1. Treatment with maintenance therapy repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study treatment. Samples are analyzed for circulating endothelial cells (by flow cytomery [FC]), circulating epithelial cells (by immunocytochemistry and FC), troponin I concentrations (by enzyme immunoassay or chemiluminescent microparticle immunoassay), and plasma renin activity (by radioimmunoassay).
After completion of study treatment, patients are followed every 4-6 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| bevacizumab | Biological | – |
| pegfilgrastim | Biological | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | – |
| flow cytometry | Other | – |
| immunoenzyme technique | Other | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
| adjuvant therapy | Procedure or surgery | – |
| immunoscintigraphy | Procedure or surgery | – |
Primary outcome
Safety
3 secondary outcomes
Noncardiac toxicity
Time to tumor recurrence
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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.
Maura N. Dickler, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bevacizumab, pegfilgrastim and cyclophosphamide in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
Safety. 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 6 Jan 2014.