Breast CancerPhase 2CAPRICENCT00563953
Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years
A Phase 2 study testing Liposomal pegylated doxorubicine in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 8 sites in Spain.
Trial summary
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Liposomal pegylated doxorubicine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesSpain
- Study dates
- Sep 2007to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer (tumor > 2 cm).
- Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
- Risk factors for developing anthracycline-induced cardiomyopathy.
Who cannot join
- Severe heart failure (NYHA Class III or IV) .
- Metastatic disease.
- LVEF < 45%.
- Pregnant or breast-feeding patients.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Morales Meseguer
Murcia, 30008
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 42301
About this study
Official title: A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.
Read the detailed description
This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.
- Conditions
- Breast Cancer
- Being tested
- Liposomal pegylated doxorubicine
- Keywords
- Breast, Cancer, Anthracyclines, Cardiopathy
- Medical subject headings
- Breast Neoplasms, Neoplasms, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal pegylated doxorubicineDrug
Also called Caelyx
Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Primary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery. Receives: Drug: Liposomal pegylated doxorubicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only.
Measured: At surgery.
Secondary outcomes (6)
Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.
Measured: Before and after treatment with paclitaxel.
Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.
Measured: At surgery.
Axillary node involvement after primary chemotherapy.
Measured: At surgery.
Left ventricular ejection fraction measured by echocardiography or MUGA.
Measured: At baseline, every 2 doxorubicine cycles and before surgery.
Cardiac sign/symptom questionnaire.
Measured: At baseline, every 2 doxorubicine cycles and before surgery.
Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry.
Measured: Until 5 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2011
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Miguel Gil, MD, Study chair, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563953
- Sponsor's protocol ID
- SOLTI0702
- Other IDs
- 2007-001428-11
- Acronym
- CAPRICE
- Status last verified
- Oct 2017
- First submitted
- 26 Nov 2007
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
PubMed 25981896Gil MJ, Bellet MC, Llombart, Ojeda B, Manso L, Mesia C, Morales S, García-Martinez H, Martínez N, Melé M, Fernández-Ortega A, Baselga J. Pegylated Liposomal Doxorubicin (PLD) as Primary Treatment in Estrogen Receptor (ER) and HER2 Poor Breast Cancer and Risk of Developing Cardiotoxicity or Elderly Patients (pt). Results from the Phase II CAPRICE Study. Cancer Research 71(24 Suppl.): 403s, 2011.(CTRC-AACR San Antonio Breast Cancer Symposium)
Gil-Gil MJ, Bellet M, Bergamino M, Morales S, Barnadas A, Manso L, Saura C, Fernandez-Ortega A, Garcia-Martinez E, Martinez-Janez N, Mele M, Villagrasa P, Celiz P, Perez Martin X, Ciruelos E, Pernas S. Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study. Front Oncol. 2021 Jul 9;11:645026. doi: 10.3389/fonc.2021.645026. eCollection 2021.
PubMed 34307126
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.
- ClinicalTrials.gov ID
- NCT00563953
- Acronym / sponsor ID
- CAPRICE / SOLTI0702
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Anthracyclines, Cardiopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Sep 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Nov 2007 (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 multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.
Detailed description
This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Liposomal pegylated doxorubicinePrimary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed invasive breast cancer (tumor > 2 cm).
- Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
- Risk factors for developing anthracycline-induced cardiomyopathy.
Key exclusion criteria (4 listed)
- Severe heart failure (NYHA Class III or IV) .
- Metastatic disease.
- LVEF < 45%.
- Pregnant or breast-feeding patients.
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 pegylated doxorubicineAlso: CaelyxFour cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery. | Drug | 1 |
Primary outcome
Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only.
Time frame: At surgery.
6 secondary outcomes
Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.
Time frame: Before and after treatment with paclitaxel.
Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.
Time frame: At surgery.
Axillary node involvement after primary chemotherapy.
Time frame: At surgery.
Left ventricular ejection fraction measured by echocardiography or MUGA.
Time frame: At baseline, every 2 doxorubicine cycles and before surgery.
Cardiac sign/symptom questionnaire.
Time frame: At baseline, every 2 doxorubicine cycles and before surgery.
Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry.
Time frame: Until 5 years after surgery.
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 12 Oct 2017.
- Background: PubMed 25981896Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
- Results publicationGil MJ, Bellet MC, Llombart, Ojeda B, Manso L, Mesia C, Morales S, García-Martinez H, Martínez N, Melé M, Fernández-Ortega A, Baselga J. Pegylated Liposomal Doxorubicin (PLD) as Primary Treatment in Estrogen Receptor (ER) and HER2 Poor Breast Cancer and Risk of Developing Cardiotoxicity or Elderly Patients (pt). Results from the Phase II CAPRICE Study. Cancer Research 71(24 Suppl.): 403s, 2011.(CTRC-AACR San Antonio Breast Cancer Symposium)
- Derived from this study: PubMed 34307126Gil-Gil MJ, Bellet M, Bergamino M, Morales S, Barnadas A, Manso L, Saura C, Fernandez-Ortega A, Garcia-Martinez E, Martinez-Janez N, Mele M, Villagrasa P, Celiz P, Perez Martin X, Ciruelos E, Pernas S. Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study. Front Oncol. 2021 Jul 9;11:645026. doi: 10.3389/fonc.2021.645026. eCollection 2021.
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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.
Miguel Gil, MD study chair
Institut Català d'Oncologia
8 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 pegylated doxorubicine in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 8 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 3 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only. (time frame: At surgery.). 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 NCT00563953, which also lists 3 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 12 Oct 2017.