Breast CancerPhase 2NCT00005980
Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 14 sites in 9 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pegylated liposomal doxorubicin hydrochloride
- How many people
- 116 participants
- Where
- 14 sitesin 9 countries
- Study dates
- Apr 2000to Jul 2002
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven progressive or recurrent metastatic breast cancer
- Bidimensionally measurable disease with at least one target lesion
- If previously irradiated lesions:
- No preirradiated only lesions
- Clear progression prior to study
- New lesions in a previously irradiated region allowed
- Refusal of or medical contraindication to standard anthracycline containing regimen
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- Transaminases less than 2 times upper limit of normal
Renal:
- Creatinine normal
Cardiovascular:
- Left ventricular ejection fraction normal by echocardiography or MUGA scan
- No significant cardiac history including:
- Clinically significant atrial or ventricular arrhythmias requiring treatment
- Medically controlled congestive heart failure
- Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
- Clinically significant valvular disease
Other:
- No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No psychological, familial, sociological, or geographical condition that would preclude study
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2
- No greater than one regimen of prior chemotherapy for metastatic disease
- No prior anthracyclines for metastatic disease
- No other concurrent cytotoxic therapy
Endocrine therapy:
- No concurrent hormonal therapy
- At least 4 weeks since prior progestins, estrogens, or androgens
Radiotherapy:
- See Disease Characteristics
- Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field
Surgery:
- Not specified
Other:
- Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
- No other concurrent investigational therapy
Trial locations and contacts
14 sites in 9 countries.
14 sites in 9 countries
France4 sites
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Institut Curie - Section Medicale
Paris, 75248
Centre Henri Becquerel
Rouen, 76038
Italy2 sites
Mario Negri Institute for Pharmacological Research
Milano (Milan), 20157
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00161
Netherlands2 sites
Academisch Ziekenhuis Groningen
Groningen, 9713 EZ
University Medical Center Nijmegen
Nijmegen, NL-6500 HB
Austria1 site
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, A-1100
About this study
Official title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.
- Assess the side effects of these treatment regimens in this patient population.
- Determine the duration of response in these patients treated with these regimens.
- Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
- Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- pegylated liposomal doxorubicin hydrochloride
- Keywords
- stage IV breast cancer, recurrent 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.
pegylated liposomal doxorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Robert E. Coleman, MD, FRCP, Study chair, Cancer Research Centre at Weston Park HospitalMaurizio D'Incalci, MD, Study chair, Mario Negri Institute for Pharmacological ResearchChristian Dittrich, MD, Study chair, Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005980
- Sponsor's protocol ID
- EORTC-10993-16998
- Other IDs
- EORTC-IDBBC-10993, ECSG-10993, PAMM-10993
- Status last verified
- Jul 2012
- First submitted
- 5 Jul 2000
- Last updated
- 18 Jul 2012
- Results posted
- No
Publications
Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. doi: 10.1016/j.critrevonc.2006.07.008. Epub 2006 Nov 20.
PubMed 17116400Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. doi: 10.1016/j.ejca.2005.12.011. Epub 2006 Mar 7.
PubMed 16520033
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00005980
- Acronym / sponsor ID
- EORTC-10993-16998
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 2000
- Primary completion
- Jul 2002 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.
- Assess the side effects of these treatment regimens in this patient population.
- Determine the duration of response in these patients treated with these regimens.
- Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
- Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Jul 2012.
- Background: PubMed 17116400Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. doi: 10.1016/j.critrevonc.2006.07.008. Epub 2006 Nov 20.
- Results publication: PubMed 16520033Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. doi: 10.1016/j.ejca.2005.12.011. Epub 2006 Mar 7.
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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.
Robert E. Coleman, MD, FRCP study chair
Cancer Research Centre at Weston Park Hospital
Maurizio D'Incalci, MD study chair
Mario Negri Institute for Pharmacological Research
Christian Dittrich, MD study chair
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
14 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 14 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2012. 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 France, Italy, Netherlands, Austria, Greece and 4 more countries. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005980, which also lists 2 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 18 Jul 2012.