Breast CancerPhase 2NCT00472693
Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer
A Phase 2 study testing Bevacizumab, Abraxane in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer. 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?
- Bevacizumab, Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2011
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 years or older and able to give informed consent.
- Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis
- ECOG performance status 0 or 1
- Life expectancy > 12 weeks
- Stage IV disease and have at least one lesion measurable by standard RECIST criteria
- Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation.
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- All chemotherapy must be stopped > 2 weeks before enrollment.
- Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory.
- Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified immunohistochemically (IHC), by an approved method using one of the standard monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH status is known, it must be negative. Testing must be done in a CLIA-approved laboratory.
- Left ventricular ejection fraction must be >= institutional lower limit of normal as determined by MUGA or echocardiogram
- Patient must be able to comply with treatment and follow-up procedures:
- Adequate bone marrow, liver and renal function; Absolute neutrophil count >= 1500/mm3; Hemoglobin >= 10 g/dl; Platelet count >= 100,000/mm3; Creatinine <= 2.0; PTT and either INR or PT < 1.5x normal; Total bilirubin <= 1.5 X upper limit of normal; AST, ALT, and alkaline phosphatase <= 2 X upper limit of normal (or <= 5X upper limit of normal if known liver metastases)
- If female is of childbearing potential, pregnancy test must be negative and patient must be willing to use effective contraception while on treatment and for at least 3 months after the last dose of study medication
Who cannot join
- Prior treatment with VEGF targeted therapy
- Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months
- History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers
- Known CNS disease
- Inadequately controlled hypertension (defined as systolic blood pressure>150 and/or diastolic blood pressure>100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
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- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer or bone fracture
- Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio >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 <1g of protein in 24 hours to be eligible)
- Patients with active infection
- Women who are pregnant or lactating
- Radiation therapy within 3 weeks of study entry
- Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or other recombinant human antibodies
- Baseline neuropathy > grade 2
- Participation in an investigational study of an antineoplastic agent within 4 weeks of first infusion of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Abraxane
- Keywords
- Breast cancer, Metastatic breast cancer, Second-Line Therapy, Triple Negative, Her-2 negative, Hormone receptor negative, Abraxane, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab, AbraxaneDrug
Bevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and ABI-007 (Abraxane) | Experimental | Bevacizumab and ABI-007 (Abraxane) Receives: Drug: Bevacizumab, Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.
Measured: Study Completion
Secondary outcomes (2)
To determine the overall response rate to bevacizumab + ABI-007 in this study population.
Measured: Study completion
To determine the toxicity of bevacizumab + ABI-007 in this study population.
Measured: Study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionApr 2011
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 Abramson Cancer Center at Penn MedicineThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Angela DeMichele, M.D., Principal investigator, Abramson Cancer Center of University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472693
- Sponsor's protocol ID
- UPCC 02106
- Status last verified
- Apr 2020
- First submitted
- 11 May 2007
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00472693
- Acronym / sponsor ID
- UPCC 02106
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Metastatic breast cancer, Second-Line Therapy, Triple Negative, Her-2 negative, Hormone receptor negative, Abraxane, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 May 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.
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and ABI-007 (Abraxane) | Experimental | Drug: Bevacizumab, AbraxaneBevacizumab and ABI-007 (Abraxane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female, aged 18 years or older and able to give informed consent.
- Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis
- ECOG performance status 0 or 1
- Life expectancy > 12 weeks
- Stage IV disease and have at least one lesion measurable by standard RECIST criteria
Key exclusion criteria (23 listed)
- Prior treatment with VEGF targeted therapy
- Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months
- History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers
- Known CNS disease
- Inadequately controlled hypertension (defined as systolic blood pressure>150 and/or diastolic blood pressure>100 mmHg on antihypertensive medications)
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, AbraxaneBevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities. | Drug | Bevacizumab and ABI-007 (Abraxane) |
Primary outcome
To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.
Time frame: Study Completion
2 secondary outcomes
To determine the overall response rate to bevacizumab + ABI-007 in this study population.
Time frame: Study completion
To determine the toxicity of bevacizumab + ABI-007 in this study population.
Time frame: Study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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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.
Angela DeMichele, M.D. principal investigator
Abramson Cancer Center of University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Abraxane in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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?
The sponsor lists 13 inclusion and 23 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 9 Apr 2020. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer. (time frame: Study Completion). 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 9 Apr 2020.