Breast NeoplasmPhase 3NCT00251095
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
A Phase 3 study testing Taxol and TOCOSOL Paclitaxel in people with Breast Neoplasm, run by Achieve Life Sciences at 14 sites in United States.
Trial summary
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with 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 Neoplasm
- What is being tested?
- Taxol and TOCOSOL Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 821 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2005to Sep 2007
- Phase
- Phase 3
- 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
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
Who cannot join
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Essex Oncology of North Jersey
Belleville, New Jersey, 07109
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Mountain State Tumor Institute
Boise, Idaho, 83712
Chattanooga Oncology & Hematology Associates, PC
Chattanooga, Tennessee, 37404
Hematology Oncology Consultants, Inc
Columbus, Ohio, 43235
Florida Cancer Specialists
Fort Myers, Florida, 33901
Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Oncology Care Associates
Saint Joseph, Michigan, 49085
Southfield Oncology Institute, Inc
Southfield, Michigan, 48076
Stockton Hematology Oncology
Stockton, California, 95204
About this study
Official title: A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
Read the detailed description
Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.
- Conditions
- Breast Neoplasm
- Being tested
- Taxol, TOCOSOL Paclitaxel
- Keywords
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxolDrug
TOCOSOL PaclitaxelDrug
100 mg/m2/week
| Study group | Role | What they receive |
|---|---|---|
| Taxol | Active comparator | Taxol 80mg/m2/week Receives: Drug: Taxol |
| TOCOSOL | Experimental | TOCOSOL Paclitaxel Receives: Drug: TOCOSOL Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates
Measured: Based on enrollment
Toxicities
Measured: Based on enrollment
Secondary outcomes (3)
Median overall survival
Measured: Based on enrollment
Progression-free survival
Measured: Based on enrollment
Time-to-disease progression
Measured: Based on enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Failed primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251095
- Sponsor's protocol ID
- SON-8184-1075
- Status last verified
- Jun 2009
- First submitted
- 8 Nov 2005
- Last updated
- 4 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00251095
- Acronym / sponsor ID
- SON-8184-1075
- Conditions
- Breast Neoplasm
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed primary endpoint
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 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.
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
Detailed description
Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxol | Active comparator | Drug: TaxolTaxol 80mg/m2/week |
| TOCOSOL | Experimental | Drug: TOCOSOL PaclitaxelTOCOSOL Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
Key exclusion criteria (2 listed)
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
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 |
|---|---|---|
| Taxol | Drug | Taxol |
| TOCOSOL Paclitaxel100 mg/m2/week | Drug | TOCOSOL |
Primary outcome
Objective response rates
Time frame: Based on enrollment
Toxicities
Time frame: Based on enrollment
3 secondary outcomes
Median overall survival
Time frame: Based on enrollment
Progression-free survival
Time frame: Based on enrollment
Time-to-disease progression
Time frame: Based on enrollment
Results and safety
The study was stopped early (reason given: Failed primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxol and TOCOSOL Paclitaxel in people with Breast Neoplasm, run by Achieve Life Sciences at 14 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 3 inclusion and 2 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 4 Jun 2009. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Failed primary endpoint). Results are not available in the source record.
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?
Objective response rates (time frame: Based on enrollment). The study lists 2 primary outcomes in all. 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 4 Jun 2009.