Breast NeoplasmsPhase 4NCT00128778
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
A Phase 4 study testing Pegylated liposomal doxorubicin in people with Breast Neoplasms, run by Spanish Breast Cancer Research Group at 1 site in Spain.
Trial summary
This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pegylated liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2002to 7 Jul 2010
- Phase
- Phase 4
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment.
- Age: at least 18 years old.
- Performance status Eastern Cooperative Oncology Group (ECOG) scale 0, 1, 2.
- Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
- Hematology: leucocytes >= 4 x 10^9/l; neutrophils >= 2.0 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin <= 10 g/dl.
- Hepatic function: total bilirubin < 1 upper limit of normal (UNL); aspartate aminotransferase (ASAT) (SGOT) and alanine aminotransferase (ALAT) (SGPT) < 2.5 UNL; alkaline phosphatase < 5 UNL. Patients with ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL and alkaline phosphatase > 2.5 UNL are not eligible.
- Renal function: creatinine < 175 mmol/l (2 mg/dl); creatinine clearance > 45 ml/min.
Who cannot join
- Pregnant or lactating patients.
- Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure.
- Hypersensitivity to anthracyclines or Cremophor®.
- Clinically significant hepatic dysfunction.
- Current uncontrolled infection.
- Mental confusion and lack of orientation.
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- Any circumstance precluding an adequate follow-up.
- Radiotherapy in the previous 4 weeks.
- Any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma.
- Symptomatic metastasis in the brain.
- Previous radiotherapy radiating a third of haematopoietic centres.
- Males.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, 28700
About this study
Official title: Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.
Read the detailed description
The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.
Patients with complete response, partial response or stable disease are eligible for 2001-01 study.
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.
- Conditions
- Breast Neoplasms
- Being tested
- Pegylated liposomal doxorubicin
- Keywords
- Breast cancer, Metastases, Maintenance treatment
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Also called Caelyx
| Study group | Role | What they receive |
|---|---|---|
| Arm A: PLD | Experimental | Pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation. Receives: Drug: Pegylated liposomal doxorubicin |
| Arm B: Observation | No intervention | Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study start28 Oct 2002
- Primary completion1 Jun 2007
- Study completion7 Jul 2010
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 NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 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 Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128778
- Sponsor's protocol ID
- GEICAM 2001-01
- Status last verified
- Mar 2023
- First submitted
- 9 Aug 2005
- Last updated
- 6 Mar 2023
- Results posted
- No
Publications
Alba E, Ruiz-Borrego M, Margeli M, Rodriguez-Lescure A, Sanchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vazquez M, Ribelles N, Calvo E, Casado A, Marquez A, Vicente D, Garcia-Saenz JA, Martin M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. doi: 10.1007/s10549-010-0860-9. Epub 2010 Apr 2.
PubMed 20361253
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00128778
- Acronym / sponsor ID
- GEICAM 2001-01
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Metastases, Maintenance treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- 28 Oct 2002 (actual)
- Primary completion
- 1 Jun 2007 (actual)
- Study completion
- 7 Jul 2010 (actual)
- First posted
- 10 Aug 2005 (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.
This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.
Detailed description
The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.
Patients with complete response, partial response or stable disease are eligible for 2001-01 study.
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: PLD | Experimental | Drug: Pegylated liposomal doxorubicinPegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation. |
| Arm B: Observation | No intervention | –Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to observation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent.
- Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment.
- Age: at least 18 years old.
- Performance status Eastern Cooperative Oncology Group (ECOG) scale 0, 1, 2.
- Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
Key exclusion criteria (12 listed)
- Pregnant or lactating patients.
- Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure.
- Hypersensitivity to anthracyclines or Cremophor®.
- Clinically significant hepatic dysfunction.
- Current uncontrolled infection.
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: Caelyx | Drug | Arm A: PLD |
Primary outcome
Time to progression (TTP)
Time frame: Through study completion, an average of 1 year
Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.
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 6 Mar 2023.
- Results publication: PubMed 20361253Alba E, Ruiz-Borrego M, Margeli M, Rodriguez-Lescure A, Sanchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vazquez M, Ribelles N, Calvo E, Casado A, Marquez A, Vicente D, Garcia-Saenz JA, Martin M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. doi: 10.1007/s10549-010-0860-9. Epub 2010 Apr 2.
- Click here for more information about this studyLink 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 Universitario Virgen de la Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated liposomal doxorubicin in people with Breast Neoplasms, run by Spanish Breast Cancer Research Group at 1 site 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 8 inclusion and 12 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 6 Mar 2023. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to progression (TTP) (time frame: Through study completion, an average of 1 year). 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 NCT00128778, 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 6 Mar 2023.