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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

At surgery.

Safety Issue:

No

Principal Investigator

Miguel Gil, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Català d'Oncologia

Authority:

Spain: Spanish Agency of Medicines

Study ID:

SOLTI0702

NCT ID:

NCT00563953

Start Date:

September 2007

Completion Date:

February 2016

Related Keywords:

  • Breast Cancer
  • Breast
  • Cancer
  • Anthracyclines
  • Cardiopathy
  • Breast Neoplasms
  • Heart Diseases

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