Clinical trial NCT00563953: Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast
Cancer
Anthracyclines
Cardiopathy
Lead sponsor: SOLTI Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2007-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: At surgery.
Secondary outcomes:
measure: Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.
timeFrame: Before and after treatment with paclitaxel.
measure: Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.
timeFrame: At surgery.
measure: Axillary node involvement after primary chemotherapy.
timeFrame: At surgery.
measure: Left ventricular ejection fraction measured by echocardiography or MUGA.
timeFrame: At baseline, every 2 doxorubicine cycles and before surgery.
measure: Cardiac sign/symptom questionnaire.
timeFrame: At baseline, every 2 doxorubicine cycles and before surgery.
measure: Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry.
timeFrame: Until 5 years after surgery.
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
Study officials:
affiliation: Institut Català d'Oncologia
name: Miguel Gil, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Gil 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)
citation: 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.