Breast CancerPhase 2ABCNCT00479674
Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer
A Phase 2 study testing Abraxane, Bevacizumab and Carboplatin in people with Breast Cancer, run by Duke University at 4 sites in United States.
Trial summary
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Abraxane, Bevacizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2007to Mar 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tissue block containing tumor to confirm metastatic breast cancer is required;
- Measurable disease according to RECIST criteria
- "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as ≤ 10% of cells staining or Allred ≤ 2;
- Aged 18 years or older;
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
- Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;
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- ≥ 2 weeks between surgery and study enrollment (≥ 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;
- Laboratory tests performed within 14 days of study entry:
- Granulocytes ≥ 1,500/µL;
- Platelets ≥ 100,000/µL;
- Hemoglobin ≥ 9 gm/dL;
- Total bilirubin ≤ institutional upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN;
- Alkaline phosphatase ≤ 2.5 times ULN;
- Estimated creatinine clearance ≥ 60 mL/min.
- left ventricular ejection fraction (LVEF)≥ 50% by multigated acquisition (MUGA)/Echocardiogram;
- Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;
- Cognitive and communication skills to comply with study and/or follow-up procedures;
- No reproductive potential:
- If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.
- If post-menopausal: Amenorrhea for ≥ 12 months.
Who cannot join
- Pregnant or breast feeding;
- Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;
- Known hypersensitivity to any component of any study drug;
- Active infection;
- Current neuropathy ≥ grade 2;
- central nervous system (CNS) metastases as determined by head CT with contrast;
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- History of bleeding within the past 6 months or active bleeding disorder;
- Serious non-healing wound, ulcer or bone fracture;
- Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;
- Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;
- Proteinuria (defined as urine protein: creatinine (UPC) ratio ≥ 1.0 or urine dipstick ≥ 2+.
- Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;
- Uncontrolled serious contraindicated medical condition or psychiatric illness.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Presbyterian Health Care
Charlotte, North Carolina, 28204
Northeast Oncology Associates
Concord, North Carolina, 28205
Duke University Medical Center
Durham, North Carolina, 27710
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103-3019
About this study
Official title: A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity.
Read the detailed description
Anthracycline-based chemotherapy is widely used as adjuvant treatment for breast cancer. In addition to the challenge posed by anthracycline-induced cardiotoxicity, there are issues surrounding previous treatment with anthracyclines which limit its utility in the metastatic disease setting. Many patients with advanced disease will have had prior anthracycline-based adjuvant therapy, may have reached a maximum cumulative lifetime dose, or developed refractory disease, creating an obvious need for non-anthracycline treatment strategies.3 Platinum- and taxane-based chemotherapies as first-line therapy for metastatic breast cancer have demonstrated significant activity, producing single-agent response rates > 50%; in combination these rates increased to > 60% in both previously untreated and in patients who previously received anthracyclines.3 However, overall survival has remained relatively unchanged.4 As there is currently no standard of care for patients with metastatic breast cancer, various physical and psychological factors must be considered when evaluating chemotherapy treatment options, including the patient's tumor biology and growth rate, presence and extent of metastases, history of prior treatment and response, sensitivity and tolerance to therapy, and quality of life.2 Strategies to develop combination, higher dose, or sequential regimens using these active agents, while improving response rates and/or time to progression, may produce increased toxicity without increased survival.2 Because metastatic breast cancer remains essentially incurable using cytotoxic therapy alone, the study of targeted biologics offers new opportunities to enhance drug delivery via their ability to regulate specific receptors that are associated with clinically aggressive disease processes.
- Conditions
- Breast Cancer
- Being tested
- Abraxane, Bevacizumab, Carboplatin
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Hormone Receptor AND Her2/neu Negative, Triple Negative, Triple Negative Breast Cancer, Stage IV or Inoperable Stage III Breast Cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called nanoparticle albumin-bound paclitaxel
100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
BevacizumabDrug
Also called Avastin
10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
CarboplatinDrug
area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
| Study group | Role | What they receive |
|---|---|---|
| Abraxane, Carboplatin, Bevacizumab | Experimental | Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15 Receives: Drug: Abraxane; Drug: Bevacizumab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
Measured: 5 years
Secondary outcomes (4)
Median Proportion Progression-free as Estimated by Kaplan-Meier Methods
PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.
Measured: 5 years
To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers
Measured: 18 months
to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy
Measured: 18 months
to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2014
- Study completionMar 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Kimberly Blackwell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479674
- Sponsor's protocol ID
- Pro00014837
- Other IDs
- AVF3962s
- Acronym
- ABC
- Status last verified
- Jan 2015
- First submitted
- 25 May 2007
- Last updated
- 18 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jasim SA, Farber IM, Noraldeen SAM, Bansal P, Alsaab HO, Abdullaev B, Alkhafaji AT, Alawadi AH, Hamzah HF, Mohammed BA. Incorporation of immunotherapies and nanomedicine to better normalize angiogenesis-based cancer treatment. Microvasc Res. 2024 Jul;154:104691. doi: 10.1016/j.mvr.2024.104691. Epub 2024 May 3.
PubMed 38703993
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00479674
- Acronym / sponsor ID
- ABC / Pro00014837
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Hormone Receptor AND Her2/neu Negative, Triple Negative, Triple Negative Breast Cancer, Stage IV or Inoperable Stage III Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc., Celgene Corporation
- Study start
- May 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity.
Detailed description
Anthracycline-based chemotherapy is widely used as adjuvant treatment for breast cancer. In addition to the challenge posed by anthracycline-induced cardiotoxicity, there are issues surrounding previous treatment with anthracyclines which limit its utility in the metastatic disease setting. Many patients with advanced disease will have had prior anthracycline-based adjuvant therapy, may have reached a maximum cumulative lifetime dose, or developed refractory disease, creating an obvious need for non-anthracycline treatment strategies.3 Platinum- and taxane-based chemotherapies as first-line therapy for metastatic breast cancer have demonstrated significant activity, producing single-agent response rates > 50%; in combination these rates increased to > 60% in both previously untreated and in patients who previously received anthracyclines.3 However, overall survival has remained relatively unchanged.4 As there is currently no standard of care for patients with metastatic breast cancer, various physical and psychological factors must be considered when evaluating chemotherapy treatment options, including the patient's tumor biology and growth rate, presence and extent of metastases, history of prior treatment and response, sensitivity and tolerance to therapy, and quality of life.2 Strategies to develop combination, higher dose, or sequential regimens using these active agents, while improving response rates and/or time to progression, may produce increased toxicity without increased survival.2 Because metastatic breast cancer remains essentially incurable using cytotoxic therapy alone, the study of targeted biologics offers new opportunities to enhance drug delivery via their ability to regulate specific receptors that are associated with clinically aggressive disease processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane, Carboplatin, Bevacizumab | Experimental | Drug: Abraxane, Drug: Bevacizumab, Drug: CarboplatinAbraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Tissue block containing tumor to confirm metastatic breast cancer is required;
- Measurable disease according to RECIST criteria
- "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as ≤ 10% of cells staining or Allred ≤ 2;
- Aged 18 years or older;
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
Key exclusion criteria (14 listed)
- Pregnant or breast feeding;
- Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;
- Known hypersensitivity to any component of any study drug;
- Active infection;
- Current neuropathy ≥ grade 2;
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 |
|---|---|---|
| AbraxaneAlso: nanoparticle albumin-bound paclitaxel100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.. | Drug | Abraxane, Carboplatin, Bevacizumab |
| BevacizumabAlso: Avastin10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death. | Drug | Abraxane, Carboplatin, Bevacizumab |
| Carboplatinarea under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death. | Drug | Abraxane, Carboplatin, Bevacizumab |
Primary outcome
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Time frame: 5 years
Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
4 secondary outcomes
Median Proportion Progression-free as Estimated by Kaplan-Meier Methods
Time frame: 5 years
To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers
Time frame: 18 months
to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy
Time frame: 18 months
to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38703993Jasim SA, Farber IM, Noraldeen SAM, Bansal P, Alsaab HO, Abdullaev B, Alkhafaji AT, Alawadi AH, Hamzah HF, Mohammed BA. Incorporation of immunotherapies and nanomedicine to better normalize angiogenesis-based cancer treatment. Microvasc Res. 2024 Jul;154:104691. doi: 10.1016/j.mvr.2024.104691. Epub 2024 May 3.
- Nab- Paclitaxel/Bevacizumab/Carboplatin chemotherapy in the first line triple negative metastatic breast cancerLink provided by the sponsor.
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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.
Kimberly Blackwell, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane, Bevacizumab and Carboplatin in people with Breast Cancer, run by Duke University at 4 sites 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?
The sponsor lists 21 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 18 Feb 2015). 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?
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00479674, which also lists 1 linked publication.
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 18 Feb 2015.