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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
SOLTI Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00563953
First received: November 26, 2007
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Liposomal pegylated doxorubicine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by SOLTI Breast Cancer Research Group:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy. [ Time Frame: At surgery. ] [ Designated as safety issue: No ]
  • Axillary node involvement after primary chemotherapy. [ Time Frame: At surgery. ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction measured by echocardiography or MUGA. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ] [ Designated as safety issue: Yes ]
  • Cardiac sign/symptom questionnaire. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ] [ Designated as safety issue: Yes ]
  • Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry. [ Time Frame: Until 5 years after surgery. ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: September 2007
Estimated Study Completion Date: February 2016
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
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.
Other Name: Caelyx

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563953

Locations
Spain
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Son Llàtzer
Palma de Mallorca, Illes Balears, Spain, 07198
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 42301
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Morales Meseguer
Murcia, Spain, 30008
Sponsors and Collaborators
SOLTI Breast Cancer Research Group
Schering-Plough
Investigators
Study Chair: Miguel Gil, MD Institut Català d'Oncologia
  More Information

No publications provided

Responsible Party: SOLTI Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00563953     History of Changes
Other Study ID Numbers: SOLTI0702, 2007-001428-11
Study First Received: November 26, 2007
Last Updated: August 9, 2012
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee

Keywords provided by SOLTI Breast Cancer Research Group:
Breast
Cancer
Anthracyclines
Cardiopathy

Additional relevant MeSH terms:
Breast Neoplasms
Heart Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cardiovascular Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014