Breast CancerPhase 2NCT00258960
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
A Phase 2 study testing Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 12 sites in Spain.
Trial summary
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks. 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?
- Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 12 sitesSpain
- Study dates
- 15 Feb 2006to 14 Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must sign an informed consent before of specific procedures of clinical trial.
- Patients with histologically confirmed breast cancer and overexpression of Her2neu.
- Age> 18 years.
- Eastern Cooperative Oncology Group (ECOG) equal or < 2.
- Patients have not been treated previously with chemotherapy for metastatic disease.
- Patients must have at least one measurable lesion according to RECIST criteria.
- Patients should have an adequate organ function to tolerate chemotherapy.
Who cannot join
- Patients with hypersensitivity reactions to any of the medications of the clinical trial.
- Patients who are pregnant or lactating are not eligible.
- Hepatic disease.
- Not controlled active infection
- Symptomatic metastatic brain cancer
- Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Juan Canalejo
A Coruña, 15006
Centro Oncológico Regional de Galicia
A Coruña, 15009
Fundación Hospital Alcorcón
Alcorcón, Madrid, 28922
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Puerta del Mar
Cadiz, 11009
Hospital Provincial de Castellón
Castelló, 12002
Complejo Hospitalario de Jaen
Jaén, 23007
Hospital Xeral Calde de Lugo
Lugo, 27004
Hospital Universitario Doce de Octubre
Madrid, 28021
Hospital Clínico Universitario San Carlos
Madrid, 28040
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
About this study
Official title: Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Read the detailed description
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
- Conditions
- Breast Cancer
- Being tested
- Liposomal Doxorubicin, Cyclophosphamide, Trastuzumab
- Keywords
- HER2 positive breast cancer, 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.
Liposomal DoxorubicinDrug
Also called Caelyx
CyclophosphamideDrug
Also called Cytoxan
TrastuzumabDrug
Also called Herceptin
| Study group | Role | What they receive |
|---|---|---|
| Caelyx,Cyclophosphamide,Trastuzumab | Other | Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) Receives: Drug: Liposomal Doxorubicin; Drug: Cyclophosphamide; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
Measured: Up to cycle 6 (24 weeks)
Secondary outcomes (4)
Time to Progression (TTP)
TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Through study treatment, and follow up period, assessed up to 88 weeks
Time to Treatment Failure (TTF)
TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first.
Measured: Through study treatment, and follow up period, assessed up to 88 weeks
Response Duration
Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred.
Measured: Through study treatment, and follow up period, assessed up to 88 weeks
Overall Survival (OS)
OS was defined as the time elapsed from first treatment until death from any cause.
Measured: Through study treatment, and follow up period, assessed up to 88 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study start15 Feb 2006
- Primary completionJul 2008
- Study completion14 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital Clínico Universitario San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258960
- Sponsor's protocol ID
- GEICAM/2004-05
- Status last verified
- Apr 2023
- First submitted
- 24 Nov 2005
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Martin M, Sanchez-Rovira P, Munoz M, Baena-Canada JM, Mel JR, Margeli M, Ramos M, Martinez E, Garcia-Saenz JA, Casado A, Jaen AM, Gonzalez-Farre X, Escudero MJ, Rodriguez-Martin C, Carrasco E; GEICAM. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 2011 Dec;22(12):2591-2596. doi: 10.1093/annonc/mdr024. Epub 2011 Mar 17.
PubMed 21421542
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu
- ClinicalTrials.gov ID
- NCT00258960
- Acronym / sponsor ID
- GEICAM/2004-05
- Conditions
- Breast Cancer
- Keywords
- HER2 positive breast cancer, Metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- 15 Feb 2006 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- 14 Jul 2009 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Detailed description
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caelyx,Cyclophosphamide,Trastuzumab | Other | Drug: Liposomal Doxorubicin, Drug: Cyclophosphamide, Drug: TrastuzumabCaelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must sign an informed consent before of specific procedures of clinical trial.
- Patients with histologically confirmed breast cancer and overexpression of Her2neu.
- Age> 18 years.
- Eastern Cooperative Oncology Group (ECOG) equal or < 2.
- Patients have not been treated previously with chemotherapy for metastatic disease.
Key exclusion criteria (6 listed)
- Patients with hypersensitivity reactions to any of the medications of the clinical trial.
- Patients who are pregnant or lactating are not eligible.
- Hepatic disease.
- Not controlled active infection
- Symptomatic metastatic brain cancer
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 |
|---|---|---|
| Liposomal DoxorubicinAlso: Caelyx | Drug | Caelyx,Cyclophosphamide,Trastuzumab |
| CyclophosphamideAlso: Cytoxan | Drug | Caelyx,Cyclophosphamide,Trastuzumab |
| TrastuzumabAlso: Herceptin | Drug | Caelyx,Cyclophosphamide,Trastuzumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to cycle 6 (24 weeks)
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
4 secondary outcomes
Time to Progression (TTP)
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Time to Treatment Failure (TTF)
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Response Duration
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Overall Survival (OS)
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21421542Martin M, Sanchez-Rovira P, Munoz M, Baena-Canada JM, Mel JR, Margeli M, Ramos M, Martinez E, Garcia-Saenz JA, Casado A, Jaen AM, Gonzalez-Farre X, Escudero MJ, Rodriguez-Martin C, Carrasco E; GEICAM. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 2011 Dec;22(12):2591-2596. doi: 10.1093/annonc/mdr024. Epub 2011 Mar 17.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
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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.
Study Director study director
Hospital Clínico Universitario San Carlos
12 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 Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 12 sites in Spain.
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 7 inclusion and 6 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rate (ORR) (time frame: Up to cycle 6 (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 NCT00258960, 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 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.