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

Breast Cancer Clinical Trial

— CAPRICE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563953
• Other study ID #: SOLTI0702
• Secondary ID: 2007-001428-11
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2007
• Last updated: October 11, 2017
• Start date: September 2007
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: SOLTI Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Heart Diseases

Intervention

Drug:
• Liposomal 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital Son Llàtzer	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario Sant Joan de Reus	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
SOLTI Breast Cancer Research Group	Schering-Plough

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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 R

Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martínez E, Martinez-Jáñez N, Melé 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. — View Citation

Outcome

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