Metastatic Breast CancerPhase 2NCT00251472
A Phase II Trial of Abraxane™ Given Weekly as a Single Agent in First-line Treatment of Metastatic Breast Cancer
A Phase 2 study testing Paclitaxel Albumin Nanoparticle for Injectable Suspension in people with Metastatic Breast Cancer, run by Veeda Oncology at 1 site in United States.
Trial summary
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer. Each cycle of treatment will be 4 weeks in length. Patients will be radiologically evaluated every 8 weeks for response. 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?
- Paclitaxel Albumin Nanoparticle for Injectable Suspension
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, patients must fulfill all of the following criteria:
- Patients must have signed an IRB-approved informed consent.
- Patients must have histologically or pathologically confirmed and documented locally advanced or metastatic breast cancer. Patients may be Her2+ or Her2-.
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension as >2 cm with conventional techniques or as >1 cm with spiral CT scan. Palpable disease is acceptable.
- Patients must be >18 years of age.
- Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).
Show all 16Show fewer
- Patients' estimated life expectancy must be at least 12 weeks.
- Patients may have received prior adjuvant chemotherapy for breast cancer, including taxane-containing regimens, provided this treatment was completed at least 12 months prior to enrollment.
- Patients may have received prior radiation (except for radiation to the entire pelvis), provided that less than 25% of the bone marrow has been treated, and the patient has recovered from the acute toxic effects of treatment prior to trial enrollment. Prior radiation treatment must have been completed at least 4 weeks prior to enrollment. Lesions that have been irradiated in the advanced disease setting may not be included as sites of measurable disease.
- Patients may have received prior hormonal, AI (aromatase inhibitors) therapy, or immunotherapy. All hormonal, AI, and immunotherapy must have been terminated prior to enrollment.
- Patients must have adequate liver function defined as: for patients with no liver metastases, aspartate transaminase (AST), alanine transaminase (ALT), and bilirubin levels can be up to 1.5 times the upper limit of normal (ULN). For patients with liver metastases, ALT, AST, and bilirubin levels can be up to 2.5 times the ULN.
- Patients must have adequate renal function defined as: creatinine < 2mg/dL or calculated creatinine clearance must be > 40mL/min.
- Patients must have adequate bone marrow function, including absolute neutrophil count (ANC) ³1500/µL, platelet count ³100,000/µL, and hemoglobin ³9 g/dL.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory testing, and be accessible for follow-up.
Who cannot join
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients who have received prior chemotherapy for the treatment of metastatic breast cancer.
- Patients who have received prior Abraxane.
- Patients who have a history of hypersensitivity to taxanes or any of the components in taxanes or Abraxane.
- Patients with serious intercurrent medical or psychiatric illness.
- Patients with a second primary malignancy, except carcinoma in situ of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated >5 years previously and with no evidence of recurrence.
Show all 10Show fewer
- Patients with only non-measurable disease, defined as all other lesions including small lesions and truly non-measurable lesions.
- Patients with parenchymal or leptomeningeal brain metastases.
- Patients planning to receive any concurrent therapy to treat metastatic or locally advanced breast cancer during the study treatment period.
- Any patient who is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.
Each cycle of treatment will be 4 weeks in length. Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Paclitaxel Albumin Nanoparticle for Injectable Suspension
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Albumin Nanoparticle for Injectable SuspensionDrug
125mg/m2 by 30-minute IV infusion, once a week.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate of Abraxane given weekly as first-line treatment for patients with locally advanced or metastatic breast cancer.
Measured: unk
Secondary outcomes (1)
To assess time to progression (TTP), overall survival (OS), and toxicities of Abraxane as first-line treatment for patients with locally advanced or metastatic breast cancer.
Measured: unk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veeda Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Barry Mirtsching, MD, Principal investigator, Veeda Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251472
- Sponsor's protocol ID
- I-04-012
- Status last verified
- May 2012
- First submitted
- 8 Nov 2005
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Abraxane™ Given Weekly as a Single Agent in First-line Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00251472
- Acronym / sponsor ID
- I-04-012
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Veeda OncologyUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Mar 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 2005 (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.
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.
Each cycle of treatment will be 4 weeks in length. Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have signed an IRB-approved informed consent.
- Patients must have histologically or pathologically confirmed and documented locally advanced or metastatic breast cancer. Patients may be Her2+ or Her2-.
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension as >2 cm with conventional techniques or as >1 cm with spiral CT scan. Palpable disease is acceptable.
- Patients must be >18 years of age.
- Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).
Key exclusion criteria (10 listed)
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients who have received prior chemotherapy for the treatment of metastatic breast cancer.
- Patients who have received prior Abraxane.
- Patients who have a history of hypersensitivity to taxanes or any of the components in taxanes or Abraxane.
- Patients with serious intercurrent medical or psychiatric illness.
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 |
|---|---|---|
| Paclitaxel Albumin Nanoparticle for Injectable Suspension125mg/m2 by 30-minute IV infusion, once a week. | Drug | – |
Primary outcome
To assess the response rate of Abraxane given weekly as first-line treatment for patients with locally advanced or metastatic breast cancer.
Time frame: unk
1 secondary outcome
To assess time to progression (TTP), overall survival (OS), and toxicities of Abraxane as first-line treatment for patients with locally advanced or metastatic breast cancer.
Time frame: unk
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 11 May 2012.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Barry Mirtsching, MD principal investigator
Veeda Oncology
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 Paclitaxel Albumin Nanoparticle for Injectable Suspension in people with Metastatic Breast Cancer, run by Veeda Oncology 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 16 inclusion and 10 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 11 May 2012. 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 assess the response rate of Abraxane given weekly as first-line treatment for patients with locally advanced or metastatic breast cancer. (time frame: unk). 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 11 May 2012.