Breast CancerPhase 2NCT00960336
Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer
A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pegylated liposomal doxorubicin hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to May 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast
- Metastatic disease as confirmed by ≥ 1 of the following:
- Histology or cytology
- Radiology
- Elevated CA 15-3 levels
- No HER2/neu overexpression by IHC or FISH
- Measurable (≥ 10 mm) or evaluable disease
- Bone lesions or isolated pleural effusion allowed
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Postmenopausal
- Life expectancy > 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 5 times ULN
- Bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 30 mL/min
- LVEF ≥ 50%
- No congestive heart failure or other uncontrolled cardiac disease
- No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
- No prior hypersensitivity to anthracyclines
- No psychological, familial, social, or geographical reason that would preclude study follow-up
- No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed
- No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
- No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
- More than 30 days since prior participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.
Secondary
- Determine the feasibility of this drug in these patients.
- Evaluate chemotherapy-induced toxicities in these patients.
- Assess the disease-free survival and overall survival of these patients.
- Study the geriatric covariates.
- Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.
After completion of study therapy, patients are followed up periodically for 2 years.
- Conditions
- Breast Cancer
- Being tested
- pegylated liposomal doxorubicin hydrochloride
- Keywords
- HER2-negative breast cancer, recurrent breast cancer, stage IV breast cancer, invasive ductal breast carcinoma, invasive lobular breast carcinoma
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicin hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Drug: pegylated liposomal doxorubicin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 3 and 6 cures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionMay 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Chauvenet, MD, Principal investigator, Hotel Dieu de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960336
- Sponsor's protocol ID
- CDR0000633600
- Other IDs
- ARCAGY-DOGMES, ARCAGY-GINECO-BR106, INCA-RECF0511, EUDRACT-2007-002736-28, SCHER-ARCAGY-DOGMES
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2009
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Falandry C, Brain E, Bonnefoy M, Mefti F, Jovenin N, Rigal O, Guillem O, El Kouri C, Uwer L, Abadie-Lacourtoisie S, Cretin J, Jacquin JP, Paraiso D, Freyer G. Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial. Eur J Cancer. 2013 Sep;49(13):2806-14. doi: 10.1016/j.ejca.2013.04.027. Epub 2013 Jun 1.
PubMed 23735702
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis
- ClinicalTrials.gov ID
- NCT00960336
- Acronym / sponsor ID
- CDR0000633600
- Conditions
- Breast Cancer
- Keywords
- HER2-negative breast cancer, recurrent breast cancer, stage IV breast cancer, invasive ductal breast carcinoma, invasive lobular breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- First posted
- 17 Aug 2009 (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, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.
Secondary
- Determine the feasibility of this drug in these patients.
- Evaluate chemotherapy-induced toxicities in these patients.
- Assess the disease-free survival and overall survival of these patients.
- Study the geriatric covariates.
- Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.
After completion of study therapy, patients are followed up periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: pegylated liposomal doxorubicin hydrochloride |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 | single arm |
Primary outcome
Response rate
Time frame: 3 and 6 cures
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 29 Oct 2014.
- Derived from this study: PubMed 23735702Falandry C, Brain E, Bonnefoy M, Mefti F, Jovenin N, Rigal O, Guillem O, El Kouri C, Uwer L, Abadie-Lacourtoisie S, Cretin J, Jacquin JP, Paraiso D, Freyer G. Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial. Eur J Cancer. 2013 Sep;49(13):2806-14. doi: 10.1016/j.ejca.2013.04.027. Epub 2013 Jun 1.
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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.
Laure Chauvenet, MD principal investigator
Hotel Dieu de Paris
1 site 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 hydrochloride in people with Breast Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Response rate (time frame: 3 and 6 cures). 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 NCT00960336, 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 29 Oct 2014.