Metastatic Breast CancerPhase 2NCT00915603
Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer
A Phase 2 study testing Everolimus, Bevacizumab and Paclitaxel in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 15 sites in United States.
Trial summary
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Everolimus, Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2009to Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients >=18 years of age.
- Histologically confirmed invasive breast cancer, locally unresectable or metastatic.
- No prior chemotherapy for MBC. Patients may have received adjuvant or
- neoadjuvant chemotherapy (including taxanes and/or bevacizumab) as long as
- treated was completed >12 months prior to relapse. Prior hormonal therapy in the
- adjuvant or metastatic setting will be permitted.
Show all 46Show fewer
- Prior hormonal therapy in the adjuvant or metastatic setting is permitted. Estrogen receptor positive patients should be considered candidates for chemotherapy.
- HER2-negative breast cancer, defined as follows:
- FISH-negative (FISH ratio <2.2), or
- IHC 0-1+, or
- IHC 2-3+ AND FISH-negative (FISH ratio <2.2).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate hematologic function, defined by:
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >=100,000/mm3
- Hemoglobin >9 g/dL
- Adequate liver function, defined by:
- AST and ALT <=2.5 x the upper limit of normal (ULN) or <=5 x ULN in
- presence of liver metastases
- Total bilirubin <=1.5 x ULN
- Adequate renal function, defined by:
- Serum creatinine <=1.5 x ULN or calculated creatinine clearance of
- >=40 ml/min
- International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial
- thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy). Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin are eligible if the INR is stable and within the therapeutic range prior to study treatment initiation.
- Adequate lipid profile: total cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglyceride 2.5 x ULN. Note: In case one or both of these thresholds are exceeded,the patient can only be included after initiation of appropriate lipid lowering medication.
- Patients with proteinuria at screening as demonstrated by either:
- Urine protein creatinine (UPC) ration >1.0 at screening
- or
- Urine dipstick for proteinuria >=2+ (patients discovered to have
- >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
- urine collection and must demonstrate <1 g of protein in 24 hours to be
- eligible).
- Measurable disease by RECIST criteria.
- Life expectancy >=12 weeks.
- Ability to swallow oral medications.
- Adequate cardiac function, defined by baseline left ventricular ejection fraction (LVEF) value >= normal per institutional guidelines by MUGA scan or
- echocardiogram (ECHO).
- Adequate recovery from recent surgery.
- Major surgical procedure >28 days from study entry
- Minor surgical procedure >7 days from study entry (Portacath placement
- excepted - patients can start treatment <7 days after portacath placement.)
- Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
- Patient must be accessible for treatment and follow-up.
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
- -
Who cannot join
- Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms < grade 2, 2) no dexamethasone requirement, and 3) follow-up MRI shows regression of lesions after treatment and no new lesions appearing.
- Previous treatment with an m-TOR inhibitor (sirolimus, temsirolimus, everolimus) or anti-angiogenesis agent unless:
- in the adjuvant setting, and
- >=12 months prior to recurrence.
- Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.
- Patients who are current receiving systemic cancer therapy or have received
Show all 34Show fewer
- previous systemic therapy within 4 weeks of the start of study drug (e.g.
- chemotherapy, antibody therapy, targeted agents).
- Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or
- diastolic pressure >100 mmHg, despite optimal medical management.
- Concurrent use of CYP3A4 inhibitors and inducers from 72 hours prior to initiation of study treatment until the end of treatment with everolimus.
- Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- History of stroke or transient ischemic attack within 6 months prior to first
- bevacizumab dose.
- Patients with any non-healing wound, ulcer, or long-bone fracture.
- Patients with clinical history of hemoptysis or hematemesis.
- Patients with any history of a bleeding diathesis or coagulopathy.
- Patients with a PEG or G tube cannot be enrolled into this trial.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
- Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Patients who have any severe and/or uncontrolled medical conditions or other
- conditions that could affect their participation such as:
- severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.
- History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
- History of hypersensitivity to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
- Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or its excipients.
- Patients with a known HIV seropositivity.
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Aventura Medical Center
Aventura, Florida, 33180
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
National Capital Clinical Research Associates
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Texas Oncology
Dallas, Texas, 75246
Fairfax Northern Virginia Hem-Onc
Fairfax, Virginia, 22031
Florida Cancer Specialists
Fort Myers, Florida, 33901
Wilshire Oncology Medical Group
LaVerne, California, 91750
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Eastern Connecticut Hematology Oncology
Norwich, Connecticut, 06360
Mercy Hospital
Portland, Maine, 04101
Virginia Cancer Institute
Richmond, Virginia, 23235
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Weekly Paclitaxel/Bevacizumab +/- Everolimus as First-Line Chemotherapy for Patients With HER2-Negative Metastatic Breast Cancer (MBC)
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or
intolerable toxicity occurs. Outcomes will be assessed for each treatment arm
separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Everolimus, Bevacizumab, Paclitaxel, Placebo
- Keywords
- Metastatic Breast Cancer, Paclitaxel, Bevacizumab, Everolimus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Systemic therapy, RAD001, Afinitor
Everolimus 10mg PO daily continuously for all 28 days of a cycle
BevacizumabDrug
Also called Systemic therapy, Avastin
Bevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle
PaclitaxelDrug
Also called Systemic therapy, Taxol
Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.
PlaceboDrug
Also called Systemic therapy
Placebo PO daily continuously for all 28 days of a cycle
BevacizumabDrug
Also called Systemic therapy, Avastin
Bevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle
PaclitaxelDrug
Also called Systemic therapy, Taxol
Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel/bevacizumab/everolimus | Active comparator | Systemic Therapy Receives: Drug: Everolimus; Drug: Bevacizumab; Drug: Paclitaxel |
| paclitaxel/bevacizumab/placebo | Placebo comparator | Systemic Therapy Receives: Drug: Placebo; Drug: Bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: every 8 weeks until progressive disease, expected average of 18 months
Secondary outcomes (4)
Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability
Assessments will be made based on the analysis of reported incidence of treatment-emergent AEs
Measured: every 4 weeks until intolerable toxicity occurs
Overall Response Rate (ORR)
The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: every 8 weeks until treatment discontinuation, expected average of 18 months
Duration of Response (DOR)
Defined as time between date of objective response and date of response to disease progression or death, as defined by RECIST v1.1 criteria. Objective response is defined as either complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: every 8 weeks until treatment discontinuation, expected average 6 months
Overall Survival (OS)
Assessed from Day 1 of study drug administration to date of death due to any cause.
Measured: every 8 weeks until treatment discontinuation, expected average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJul 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.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Denise A. Yardley, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915603
- Sponsor's protocol ID
- SCRI BRE 154
- Status last verified
- Dec 2014
- First submitted
- 4 Jun 2009
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Weekly Paclitaxel/Bevacizumab +/- Everolimus as First-Line Chemotherapy for Patients With HER2-Negative Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT00915603
- Acronym / sponsor ID
- SCRI BRE 154
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Paclitaxel, Bevacizumab, Everolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or
intolerable toxicity occurs. Outcomes will be assessed for each treatment arm
separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel/bevacizumab/everolimus | Active comparator | Drug: Everolimus, Drug: Bevacizumab, Drug: PaclitaxelSystemic Therapy |
| paclitaxel/bevacizumab/placebo | Placebo comparator | Drug: Placebo, Drug: Bevacizumab, Drug: PaclitaxelSystemic Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Female or male patients >=18 years of age.
- Histologically confirmed invasive breast cancer, locally unresectable or metastatic.
- No prior chemotherapy for MBC. Patients may have received adjuvant or
- neoadjuvant chemotherapy (including taxanes and/or bevacizumab) as long as
- treated was completed >12 months prior to relapse. Prior hormonal therapy in the
Key exclusion criteria (34 listed)
- Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms < grade 2, 2) no dexamethasone requirement, and 3) follow-up MRI shows regression of lesions after treatment and no new lesions appearing.
- Previous treatment with an m-TOR inhibitor (sirolimus, temsirolimus, everolimus) or anti-angiogenesis agent unless:
- Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.
- Patients who are current receiving systemic cancer therapy or have received
- previous systemic therapy within 4 weeks of the start of study drug (e.g.
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 |
|---|---|---|
| EverolimusAlso: Systemic therapy, RAD001, AfinitorEverolimus 10mg PO daily continuously for all 28 days of a cycle | Drug | paclitaxel/bevacizumab/everolimus |
| BevacizumabAlso: Systemic therapy, AvastinBevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle | Drug | paclitaxel/bevacizumab/everolimus |
| PaclitaxelAlso: Systemic therapy, TaxolPaclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction. | Drug | paclitaxel/bevacizumab/everolimus |
| PlaceboAlso: Systemic therapyPlacebo PO daily continuously for all 28 days of a cycle | Drug | paclitaxel/bevacizumab/placebo |
| BevacizumabAlso: Systemic therapy, AvastinBevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle | Drug | paclitaxel/bevacizumab/placebo |
| PaclitaxelAlso: Systemic therapy, TaxolPaclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction. | Drug | paclitaxel/bevacizumab/placebo |
Primary outcome
Progression-Free Survival (PFS)
Time frame: every 8 weeks until progressive disease, expected average of 18 months
Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
4 secondary outcomes
Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: every 4 weeks until intolerable toxicity occurs
Overall Response Rate (ORR)
Time frame: every 8 weeks until treatment discontinuation, expected average of 18 months
Duration of Response (DOR)
Time frame: every 8 weeks until treatment discontinuation, expected average 6 months
Overall Survival (OS)
Time frame: every 8 weeks until treatment discontinuation, expected average 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- 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.
Denise A. Yardley, M.D. study chair
SCRI Development Innovations, LLC
15 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 Everolimus, Bevacizumab and Paclitaxel in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 15 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 46 inclusion and 34 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 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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 22 Dec 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?
Progression-Free Survival (PFS) (time frame: every 8 weeks until progressive disease, expected average of 18 months). 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 22 Dec 2014.