NCT00296010

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

Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx, Doxil) for Women (Age 66 Years or Older) With Endocrine Nonresponsive Breast Cancer Who Are Not Suitable for Being Offered a " Standard Chemotherapy Regimen"

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 66 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Compare the breast cancer-free interval in elderly women with resectable, hormone receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride liposome (PDL) vs observation or PDL vs cyclophosphamide and methotrexate. Secondary * Compare the tolerability of these regimens in these patients. * Compare the safety and toxic effects of these regimens in these patients. * Compare the overall and progression-free survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the sites of failure in patients treated with these regimens. * Compare the competing causes of death in patients treated with these regimens. * Compare the rate of second non-breast malignancy in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are assigned, based on patient preference, to 1 of 2 treatment groups. * Group 1: Patients are randomized to 1 of 2 arms (arms I and II). * Arm I: Patients receive pegylated doxorubicin hydrochloride liposome (PDL) IV over 1 hour on day 1. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation only. * Group 2: Patients are randomized to 1 of 2 treatment arms (arms III and IV). * Arm III: Patients receive PDL as in arm I. * Arm IV: Patients receive oral cyclophosphamide once daily on days 1-7 and oral methotrexate twice daily on days 1 and 4. Treatment repeats every week for 16 courses in the absence of disease progression or unacceptable toxicity. All patients may undergo radiotherapy according to institutional standards either during surgery or after the completion of chemotherapy. Quality of life is assessed at baseline and at 3, 6, and 12 months. After completion of study treatment, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2006-02-24
• Last updated: 2021-02-23

Locations

33 sites across 9 countries: Australia, Belgium, Hungary, Italy, New Zealand, Romania, Slovenia, Sweden, Switzerland