Metastatic Breast CancerPhase 2NCT00274456
Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer
A Phase 2 study testing ABI-007 and Docetaxel in people with Metastatic Breast Cancer, run by Celgene at 1 site in Ukraine.
Trial summary
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- ABI-007 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Nov 2005to 1 Jul 2011
- 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
- Patients had to meet the following criteria to be eligible for the study:
- Pathologically confirmed adenocarcinoma of the breast.
- No prior chemotherapy for metastatic breast cancer.
- Stage IV disease.
- Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were ≥ 1.0 cm).
- At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.
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- At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.
- At least 4 weeks since major surgery, with full recovery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Age ≥18 years.
- Patient had the following blood counts at Baseline:
- Absolute neutrophil count (ANC) ≥1.5*10^9 cells/L
- Platelets ≥100*10^9 cells/L
- Hemoglobin (Hgb) ≥9 g/dL.
- Patient had the following baseline blood chemistry levels:
- Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT])≥2.5x upper limit of normal (ULN) range
- Total bilirubin normal
- Alkaline phosphatase ≥2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)
- Creatinine ≥1.5 mg/dL.
- Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).
- If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.
- Informed consent had been obtained.
Who cannot join
- Patients who met any of the following criteria were excluded from the study:
- Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.
- Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.
- Concurrent immunotherapy or hormonal therapy for breast cancer.
- Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- Serious intercurrent medical or psychiatric illness, including serious active infection.
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- History of class II-IV congestive heart failure.
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- Patients who had received an investigational drug within the previous 3 weeks.
- Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.
- Pregnant or nursing women
- Patients with prior hypersensitivity to either Taxol or Taxotere.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
Read the detailed description
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:
- the maximum tolerated dose (MTD) of ABI-007 300 mg/m^2 every 3 weeks;
- ABI-007 100 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- ABI-007 150 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- the standard dose and schedule of Taxotere (100 mg/m^2 every 3 weeks).
- Conditions
- Metastatic Breast Cancer
- Being tested
- ABI-007, Docetaxel
- Keywords
- Metastatic breast cancer, nab paclitaxel, docetaxel,
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-007Drug
Also called Abraxane®, nab®-paclitaxel
ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.
DocetaxelDrug
Also called Taxotere
Docetaxel dosed q3w at 100 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| ABI-007 300 mg/m^2 q3w | Experimental | ABI-007 300 mg/m^2 administered once every third week (q3w). Receives: Drug: ABI-007 |
| ABI-007 100 mg/m^2 weekly | Experimental | ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest Receives: Drug: ABI-007 |
| ABI-007 150 mg/m^2 weekly | Experimental | ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest Receives: Drug: ABI-007 |
| Docetaxel 100 mg/m^2, q3w | Active comparator | Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w). Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator
Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.
Measured: Day 1 up to 95 weeks
Secondary outcomes (6)
Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response
Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately
Measured: Day 1 up to 95 weeks
Kaplan-Meier Estimates for Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Measured: Day 1 up to 95 weeks
Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression
Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.
Measured: Day 1 - 95 weeks
Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression
Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.
Measured: Day 1 - 95 weeks
Kaplan-Meier Estimate for Overall Survival (OS)
Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).
Measured: Day 1 to 221 weeks
Participants With Treatment-Emergent, Treatment-Related Adverse Events
Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.
Measured: Day 1 up to 125 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study start1 Nov 2005
- Primary completion1 Mar 2008
- Study completion1 Jul 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Iglesias, MD, Study chair, Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274456
- Sponsor's protocol ID
- CA024
- Status last verified
- Nov 2019
- First submitted
- 10 Jan 2006
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
O'Shaughnessy J, Gradishar WJ, Bhar P, Iglesias J. Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis. Breast Cancer Res Treat. 2013 Apr;138(3):829-37. doi: 10.1007/s10549-013-2447-8. Epub 2013 Apr 6.
PubMed 23563958Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9. doi: 10.1200/JCO.2008.18.5397. Epub 2009 May 26.
PubMed 19470941Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P, McGuire JR, Iglesias J. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival. Clin Breast Cancer. 2012 Oct;12(5):313-21. doi: 10.1016/j.clbc.2012.05.001. Epub 2012 Jun 23.
PubMed 22728026
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer
- ClinicalTrials.gov ID
- NCT00274456
- Acronym / sponsor ID
- CA024
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, nab paclitaxel, docetaxel,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2005 (actual)
- Primary completion
- 1 Mar 2008 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
Detailed description
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:
- the maximum tolerated dose (MTD) of ABI-007 300 mg/m^2 every 3 weeks;
- ABI-007 100 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- ABI-007 150 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- the standard dose and schedule of Taxotere (100 mg/m^2 every 3 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABI-007 300 mg/m^2 q3w | Experimental | Drug: ABI-007ABI-007 300 mg/m^2 administered once every third week (q3w). |
| ABI-007 100 mg/m^2 weekly | Experimental | Drug: ABI-007ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest |
| ABI-007 150 mg/m^2 weekly | Experimental | Drug: ABI-007ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest |
| Docetaxel 100 mg/m^2, q3w | Active comparator | Drug: DocetaxelDocetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pathologically confirmed adenocarcinoma of the breast.
- No prior chemotherapy for metastatic breast cancer.
- Stage IV disease.
- Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were ≥ 1.0 cm).
- At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.
Key exclusion criteria (12 listed)
- Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.
- Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.
- Concurrent immunotherapy or hormonal therapy for breast cancer.
- Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- Serious intercurrent medical or psychiatric illness, including serious active infection.
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 |
|---|---|---|
| ABI-007Also: Abraxane®, nab®-paclitaxelABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment. | Drug | ABI-007 100 mg/m^2 weekly, ABI-007 150 mg/m^2 weekly, ABI-007 300 mg/m^2 q3w |
| DocetaxelAlso: TaxotereDocetaxel dosed q3w at 100 mg/m^2 | Drug | Docetaxel 100 mg/m^2, q3w |
Primary outcome
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator
Time frame: Day 1 up to 95 weeks
Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.
6 secondary outcomes
Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response
Time frame: Day 1 up to 95 weeks
Kaplan-Meier Estimates for Progression-free Survival (PFS)
Time frame: Day 1 up to 95 weeks
Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression
Time frame: Day 1 - 95 weeks
Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression
Time frame: Day 1 - 95 weeks
Kaplan-Meier Estimate for Overall Survival (OS)
Time frame: Day 1 to 221 weeks
Participants With Treatment-Emergent, Treatment-Related Adverse Events
Time frame: Day 1 up to 125 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23563958O'Shaughnessy J, Gradishar WJ, Bhar P, Iglesias J. Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis. Breast Cancer Res Treat. 2013 Apr;138(3):829-37. doi: 10.1007/s10549-013-2447-8. Epub 2013 Apr 6.
- Results publication: PubMed 19470941Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9. doi: 10.1200/JCO.2008.18.5397. Epub 2009 May 26.
- Results publication: PubMed 22728026Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P, McGuire JR, Iglesias J. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival. Clin Breast Cancer. 2012 Oct;12(5):313-21. doi: 10.1016/j.clbc.2012.05.001. Epub 2012 Jun 23.
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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.
Jose Iglesias, MD study chair
Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation
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 ABI-007 and Docetaxel in people with Metastatic Breast Cancer, run by Celgene at 1 site in Ukraine.
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 23 inclusion and 12 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 21 Nov 2019. 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 Ukraine. 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 2 Jul 2013). 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?
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator (time frame: Day 1 up to 95 weeks). 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 NCT00274456, which also lists 3 linked publications.
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 21 Nov 2019.