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

NCT ID: NCT00563953

Last Updated: 2017-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Anthracyclines; Cardiopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal pegylated doxorubicine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Caelyx

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

SOLTI Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Gil, MD

Role: STUDY_CHAIR

Institut Català d'Oncologia

Locations

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Morales Meseguer

Murcia, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 25981896 (View on PubMed)

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)

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 34307126 (View on PubMed)

Other Identifiers

2007-001428-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SOLTI0702

Identifier Type: -

Identifier Source: org_study_id