Breast CancerPhase 2NCT01206881
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
A Phase 2 study testing pegylated liposomal doxorubicin in people with Breast Cancer, run by Herlev Hospital at 4 sites in Denmark.
Trial summary
The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pegylated liposomal doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2009to Jun 2011
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically proven breast cancer
- inflammatory, locally advanced breast cancer or a tumor > 5 cm
- ECOG performance status < 2
- LVEF > 50% measured by MUGA (HER2 positive patients)
- adequate bone marrow, liver and renal function
- written informed consent must be obtained
Who cannot join
- another malignancy within 5 years prior to study entry
- concurrent treatment with an investigational agent
- other disease or condition that contraindicates participation in the study
- pregnant or lactating females
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Herlev Hospital
Herlev
Odense University Hospital
Odense, 5000
About this study
Official title: A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.
Read the detailed description
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.
- Conditions
- Breast Cancer
- Being tested
- pegylated liposomal doxorubicin
- Keywords
- breast cancer, neoadjuvant, liposomal doxorubicin, PET scan
- 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 doxorubicinDrug
Also called cyclophosphamide, 4 cycles, docetaxel, 4 cycles, trastuzumab, 8 cycles
35 mg/m2, IV, day 1 every 21 days, 4 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response rate
evaluation of treatment efficacy every 2.cycle
Measured: 24 weeks
Secondary outcomes (1)
pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital
- Investigators
- Malgorzata K Tuxen, MD, Principal investigator, Herlev Hospital, Department of OncologyUlla B Tange, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletSoeren Cold, MD, Principal investigator, Odense University HospitalSusanne B Søndergaard, MD, Principal investigator, Herlev HospitalHenrik Petersen, MD, Principal investigator, Odense University HospitalInger Hoejris, MD, Principal investigator, Aarhus University HospitalAnni Eskild-Jensen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206881
- Sponsor's protocol ID
- PO5903, EudraCT 2008-007951-29
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuxen MK, Cold S, Tange UB, Balslev E, Nielsen DL. Phase II study of neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in locally advanced breast cancer. Acta Oncol. 2014 Oct;53(10):1440-5. doi: 10.3109/0284186X.2014.921727. Epub 2014 Jul 3. No abstract available.
PubMed 24991893
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01206881
- Acronym / sponsor ID
- PO5903, EudraCT 2008-007951-29
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant, liposomal doxorubicin, PET scan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Sep 2010 (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 determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.
Detailed description
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathologically proven breast cancer
- inflammatory, locally advanced breast cancer or a tumor > 5 cm
- ECOG performance status < 2
- LVEF > 50% measured by MUGA (HER2 positive patients)
- adequate bone marrow, liver and renal function
Key exclusion criteria (4 listed)
- another malignancy within 5 years prior to study entry
- concurrent treatment with an investigational agent
- other disease or condition that contraindicates participation in the study
- pregnant or lactating females
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 doxorubicinAlso: cyclophosphamide, 4 cycles, docetaxel, 4 cycles, trastuzumab, 8 cycles35 mg/m2, IV, day 1 every 21 days, 4 cycles | Drug | – |
Primary outcome
clinical response rate
Time frame: 24 weeks
evaluation of treatment efficacy every 2.cycle
1 secondary outcome
pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen
Time frame: up to 30 weeks
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 4 Jul 2011.
- Derived from this study: PubMed 24991893Tuxen MK, Cold S, Tange UB, Balslev E, Nielsen DL. Phase II study of neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in locally advanced breast cancer. Acta Oncol. 2014 Oct;53(10):1440-5. doi: 10.3109/0284186X.2014.921727. Epub 2014 Jul 3. No abstract available.
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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.
Malgorzata K Tuxen, MD principal investigator
Herlev Hospital, Department of Oncology
Ulla B Tange, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Soeren Cold, MD principal investigator
Odense University Hospital
4 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 in people with Breast Cancer, run by Herlev Hospital at 4 sites in Denmark.
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 6 inclusion and 4 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 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
clinical response rate (time frame: 24 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 NCT01206881, 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 4 Jul 2011.