Breast CancerPhase 2NCT00518583
Phase II Study in Patients With Operable Breast Cancer
A Phase 2 study testing Pegylated Liposomal Doxorubicin (Doxil) in people with Breast Cancer, run by Aptium Oncology Research Network at 9 sites in United States.
Trial summary
The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pegylated Liposomal Doxorubicin (Doxil)
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2006to Sep 2009
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dx of clinical T1c-T3, N0-1, M0 breast cancer
- Interval between diagnosis and consent of <- 62 days
- Life expectancy of 10 years
- LVEF by MUGA >= lower limit of normal for the testing facility
- Negative serum pregnancy test
- Adequate bone marrow, renal, liver function
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- Negative bone scan
- HRT discontinued before study entry
- Adequate contraceptive methods
Who cannot join
- Male breast cancer
- Less than 21 years of age
- Ulceration, infiltration of the skin, complete fixation or severe skin edema
- N3 disease in which nodes are matted and fixed
- Suspicious palpable supraclavicular nodes
- CT evidence of malignant internal mammary nodes
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- Pregnancy or breast feeding at time of study entry
- Prior therapy for breast cancer
- Prior anthracycline for any malignancy
- Prior breast malignancy of the contralateral breast
- Prior non-breast malignancy within 5 years
- Non-malignant disease that would preclude follow up
- MI within 6 months, NYHA Class II or greater heart failure
- Psychiatric disorders or conditions that would preclude provision of informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lynn Regional Cancer Center West
Boca Raton, Florida, 33486
Maimonides Cancer Center
Brooklyn, New York, 11220
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence St. Joseph Medical Hospital
Burbank, California, 91505
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45221
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048
St Vincent Comprehensive Cancer Center
New York, New York, 10011
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, 92262
About this study
Official title: A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu
The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
- Conditions
- Breast Cancer
- Being tested
- Pegylated Liposomal Doxorubicin (Doxil)
- Keywords
- Breast cancer, Over-expressing Her2-neu
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal Doxorubicin (Doxil)Drug
Also called taxol (paclitaxel), herceptin
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
Measured: within 18 weeks
Secondary outcomes (5)
Identify the complete response rate
Measured: within 18 weeks
Identify the partial response rate
Measured: within 18 weeks
Identify the overall response rate
Measured: within 18 weeks
Evaluate changes in cardiac function
Measured: within study participation
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
Measured: within study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionJan 2009 (estimated)
- Study completionSep 2009 (estimated)
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptium Oncology Research Network
- Sponsor type
- Research network
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- John Macdonald, MD, Study director, CMO Aptium Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518583
- Sponsor's protocol ID
- 06BR01
- Status last verified
- Jan 2010
- First submitted
- 16 Aug 2007
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu
- ClinicalTrials.gov ID
- NCT00518583
- Acronym / sponsor ID
- 06BR01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Over-expressing Her2-neu
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aptium Oncology Research NetworkResearch network
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Oct 2006
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 20 Aug 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 study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dx of clinical T1c-T3, N0-1, M0 breast cancer
- Interval between diagnosis and consent of <- 62 days
- Life expectancy of 10 years
- LVEF by MUGA >= lower limit of normal for the testing facility
- Negative serum pregnancy test
Key exclusion criteria (14 listed)
- Male breast cancer
- Less than 21 years of age
- Ulceration, infiltration of the skin, complete fixation or severe skin edema
- N3 disease in which nodes are matted and fixed
- Suspicious palpable supraclavicular nodes
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 |
|---|---|---|
| Pegylated Liposomal Doxorubicin (Doxil)Also: taxol (paclitaxel), herceptinDoxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly | Drug | – |
Primary outcome
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
Time frame: within 18 weeks
5 secondary outcomes
Identify the complete response rate
Time frame: within 18 weeks
Identify the partial response rate
Time frame: within 18 weeks
Identify the overall response rate
Time frame: within 18 weeks
Evaluate changes in cardiac function
Time frame: within study participation
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
Time frame: within study participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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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.
John Macdonald, MD study director
CMO Aptium Oncology
9 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 Pegylated Liposomal Doxorubicin (Doxil) in people with Breast Cancer, run by Aptium Oncology Research Network at 9 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
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?
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab (time frame: within 18 weeks). 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 15 Jan 2010.