Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563953

Acronym

CAPRICE

Enrollment

Registered

2007-11-27

Start date

2007-09-30

Completion date

2016-08-31

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast, Cancer, Anthracyclines, Cardiopathy

Brief 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.

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.

Interventions

DRUGLiposomal pegylated doxorubicine

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Severe heart failure (NYHA Class III or IV) . * Metastatic disease. * LVEF \< 45%. * Pregnant or breast-feeding patients.

Design outcomes

Primary

Measure	Time frame
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.	At surgery.

Secondary

Measure	Time frame
Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.	At surgery.
Axillary node involvement after primary chemotherapy.	At surgery.
Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.	Before and after treatment with paclitaxel.
Cardiac sign/symptom questionnaire.	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.	Until 5 years after surgery.
Left ventricular ejection fraction measured by echocardiography or MUGA.	At baseline, every 2 doxorubicine cycles and before surgery.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026