Metastatic Breast CancerPhase 2NCT00456846
First Line Therapy for Patients With Metastatic Breast Cancer
A Phase 2 study testing ABI-007 in people with Metastatic Breast Cancer, run by Celgene at 14 sites in Canada.
Trial summary
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 14 sitesCanada
- Study dates
- 1 Feb 2008to 31 May 2013
- 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
- Females with pathologically confirmed adenocarcinoma of the breast.
- No prior chemotherapy for metastatic breast cancer
- At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease
- Stage IV disease
- Measurable disease (must be equal or greater to 2.0 cm using conventional Computed Tomography (CT) or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm)
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal
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- At least 4 weeks since major surgery, with full recovery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age equal or greater to 18
- Patients has the following blood counts at Baseline:
- Absolute Neutrophil Count (ANC) equal or greater to 1.5 x 10^9 cells/L
- Platelets equal or greater to 100 x 10^9 cells/L
- Hemoglobin (Hgb) equal or greater to 90 grams/L
- Patients has the following blood chemistry levels at Baseline:
- Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic:pyruvic transaminase (SGPT)less than or equal to 2.5x upper limit of normal range (ULN);
- total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease);
- alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- Creatinine less than or equal to 1.5mg/dL
- Current sensory neuropathy Grade 0 or 1 by Breast Cancer Index (BCI) Common Toxicity Criteria Adverse Events (CTCAE)
- If female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug).
- If fertile, the patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study
- Patient is able to supply unstained slides or 1 tumor block of her primary breast tumor or a biopsy of a current site of metastasis for Secreted protein acidic and rich in cysteine (SPARC) analysis
- Informed consent has been obtained
Who cannot join
- Concurrent immunotherapy or hormonal therapy (other than Herceptin) 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
- History of class II-IV congestive heart failure
- History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Patients who have received an investigational drug within the previous 3 weeks
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- Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study.
- Pregnant or nursing women
- Patients with prior hypersensitivity to Taxol or Taxotere
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
The Royal Victoria Hospital
Barrie, Ontario
BC Cancer Agency-Burnaby
Burnaby, British Columbia
Hospital de la Cite-de-la Sante-de-Laval
Laval, Quebec
London Regional Cancer Centre
London, Ontario
Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu
Montreal, Quebec
McGill University
Montreal, Quebec
Lions Gate Hospital
North Vancouver, British Columbia
CHA: Saint Sacrement Hospital
Québec
Dr. H. Bliss Murphy Cancer Center
St. John's, Newfoundland and Labrador
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto Synnybrook Cancer Centre
Toronto, Ontario
B.C.C.A Vancouver Island Center
Victoria, British Columbia
Windsor Regional Hospital
Windsor, Ontario
About this study
Official title: An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
Read the detailed description
This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.
The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.
- Conditions
- Metastatic Breast Cancer
- Being tested
- ABI-007
- Keywords
- Metastatic Breast Cancer, ABI-007, Abraxane
- 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 Nab-paclitaxel, Abraxane
100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest
| Study group | Role | What they receive |
|---|---|---|
| ABI-007 | Experimental | 100 mg/m^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity. Receives: Drug: ABI-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers
Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits
Measured: Every 8 weeks from study start until disease progression; Up to 61 months
Secondary outcomes (7)
Percentage of Participants With Disease Control
Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Measured: Every 8 weeks from study start until disease progression; Up to 61 months
Progression-free Survival (PFS)
PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Measured: Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months
Duration of Response Based on Independent Reviewer Assessment
Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Duration of Response Based on Investigator Assessment
Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Patient Survival
Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.
Measured: Study start until death, or until data cut-off 31 May 2013; up to 61 months
Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug
The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Measured: Day 1 of study drug to Day 940; data cut off 31 May 2013
Number of Participants With Treatment-Emergent Adverse Events
Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. 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 to Day 940
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study start1 Feb 2008
- Primary completion11 Dec 2012
- Study completion31 May 2013
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sasha Smiljanik, MD, Principal investigator, Lions Gate HospitalKara Laing, MD, Principal investigator, Dr. H. Bliss Murphy Cancer CenterWendy Lam, MD, Principal investigator, BC Cancer Agency-BurnabyMaureen Trudeau, MD, Principal investigator, Toronto Sunnybrook Cancer CentreVanessa Bernstein, MD, Principal investigator, B.C.C.A. Vancouver Island CenterJawaid Younus, MD, Principal investigator, London Regional Cancer CentreLawrence Panasci, MD, Principal investigator, McGill UniversityGuy Cantin, MD, Principal investigator, CHA: Saint Sacrement Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456846
- Sponsor's protocol ID
- CA042
- Status last verified
- Nov 2019
- First submitted
- 3 Apr 2007
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brezden B, et al. An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update. Presented at 2010 ASCO Annual Meeting, June 4-8, 2010, Chicago, IL. Abstract No 1127 C.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00456846
- Acronym / sponsor ID
- CA042
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, ABI-007, Abraxane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 123 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2008 (actual)
- Primary completion
- 11 Dec 2012 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 18 Jul 2014
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 the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
Detailed description
This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.
The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI-007 | Experimental | Drug: ABI-007100 mg/m^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity. |
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)
- Females with pathologically confirmed adenocarcinoma of the breast.
- No prior chemotherapy for metastatic breast cancer
- At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease
- Stage IV disease
- Measurable disease (must be equal or greater to 2.0 cm using conventional Computed Tomography (CT) or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm)
Key exclusion criteria (9 listed)
- Concurrent immunotherapy or hormonal therapy (other than Herceptin) 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
- History of class II-IV congestive heart failure
- History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
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: Nab-paclitaxel, Abraxane100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest | Drug | ABI-007 |
Primary outcome
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers
Time frame: Every 8 weeks from study start until disease progression; Up to 61 months
Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits
7 secondary outcomes
Percentage of Participants With Disease Control
Time frame: Every 8 weeks from study start until disease progression; Up to 61 months
Progression-free Survival (PFS)
Time frame: Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months
Duration of Response Based on Independent Reviewer Assessment
Time frame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Duration of Response Based on Investigator Assessment
Time frame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Patient Survival
Time frame: Study start until death, or until data cut-off 31 May 2013; up to 61 months
Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug
Time frame: Day 1 of study drug to Day 940; data cut off 31 May 2013
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 940
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBrezden B, et al. An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update. Presented at 2010 ASCO Annual Meeting, June 4-8, 2010, Chicago, IL. Abstract No 1127 C.
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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.
Sasha Smiljanik, MD principal investigator
Lions Gate Hospital
Kara Laing, MD principal investigator
Dr. H. Bliss Murphy Cancer Center
Wendy Lam, MD principal investigator
BC Cancer Agency-Burnaby
14 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 ABI-007 in people with Metastatic Breast Cancer, run by Celgene at 14 sites in Canada.
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 9 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: stopped early, as of the sponsor's last update on 22 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 14 sites in Canada. 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 Jul 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?
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers (time frame: Every 8 weeks from study start until disease progression; Up to 61 months). 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 NCT00456846, 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 22 Nov 2019.