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Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

NCT00296010 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-02-23

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer.

PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.

Conditions

Interventions

DRUG

cyclophosphamide

cyclophosphamide 50 mg/day orally continuously for 16 weeks

DRUG

methotrexate

methotrexate 2.5 mg twice a day orally on days 1 and 4 of every week for 16 weeks

DRUG

pegylated liposomal doxorubicin hydrochloride

Caelyx (R) (Doxil (R)) 20 mg/m2 iv x 8 doses (delivered every 2 weeks)

PROCEDURE

adjuvant therapy

RADIATION

radiation therapy

Radiation therapy should be used according to institutional accepted guidelines. Radiation therapy to the conserved breast is recommended. Radiation therapy to the chest wall following mastectomy is optional (if given, it may also include nodal fields). Radiation therapy may be given either during operation or after all chemotherapy.

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Diana Crivellari, MD · Centro di Riferimento Oncologico, Aviano (Italy)

  • Silvia Dellapasqua, MD · European Institute of Oncology, Milano (Italy)

  • Anne Hamilton, MD · Royal Prince Alfred Hospital, Camperdown (Australia)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
66 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Australia
  • Belgium
  • Hungary
  • Italy
  • New Zealand
  • Romania
  • Slovenia
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00296010 on ClinicalTrials.gov