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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Breast Cancer Study Group
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Disease must be confined to the breast and axillary nodes without detected masses elsewhere

• No history of prior ipsilateral or contralateral invasive breast cancer

• Resected disease

• No more than 16 weeks since last surgery to remove the tumor

• No known clinical residual locoregional disease

• Margins must be negative for invasive breast cancer and ductal carcinoma in situ

• No locally advanced, inoperable breast cancer including any of the following:

• Inflammatory breast cancer

• Supraclavicular node involvement

• Enlarged internal mammary nodes unless pathologically negative

• Synchronous bilateral invasive breast cancer (diagnosed in the past 2 months) allowed if all tumors are hormone receptor-negative

• Must not be a candidate for endocrine therapy or standard chemotherapy

• Hormone receptor-negative disease

PATIENT CHARACTERISTICS:

• Female

• Menopausal status: postmenopausal

• ECOG performance status 0-2

• Platelet count ≥ 100,000/mm^3

• Granulocyte count ≥ 1,500/mm^3

• WBC ≥ 3,000/mm^3

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin normal

• Creatinine clearance ≥ 50 mL/min

• Creatinine < 1.35 mg/dL

• No significant malabsorption syndrome or disease affecting gastrointestinal tract function

• No myocardial infarction within the past 6 months

• No pulmonary embolism within the past 6 months

• No deep vein thrombosis within the past 6 months

• No New York Heart Association class III or IV heart disease

• LVEF ≥ 50% by echocardiography, radionucleotide ventriculography, or MUGA

• No evidence of acute ischemia by ECG

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, or ipsilateral or contralateral breast carcinoma in situ

• No active, uncontrolled infection

• No active hepatitis B or C virus infection

• No other chronic infection

• Patients must not have any of the following "geriatric syndromes":

• Dementia

• Delirium

• Major depression (as diagnosed by a psychiatrist)

• Recent falls

• Spontaneous bone fractures

• Neglect

• Abuse

• No evidence of medically relevant conduction system abnormalities that would preclude study entry

• No other nonmalignant, uncontrolled systemic diseases, psychiatric illness, or addictive or cognitive disorder that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior raloxifene, tamoxifen citrate, or other selective estrogen receptor modulators (SERMs)

• No concurrent recombinant human epoetin alfa or pegfilgrastim

• No prior neoadjuvant or adjuvant therapy for breast cancer except radiotherapy

• Concurrent trastuzumab (Herceptin®) allowed

• No concurrent hormonal replacement therapy

• No other concurrent hormonal therapy (including estrogen, progesterone, androgens, tamoxifen citrate, SERMs, or aromatase inhibitors) except for the following:

• Steroids for adrenal failure

• Hormones for non-disease-related conditions (e.g., insulin for diabetes)

• Intermittent dexamethasone as an antiemetic

• No other concurrent investigational agents

• No concurrent bisphosphonates, except for the treatment of osteoporosis

• For patients who received prior anthracyclines, the following criteria must be met:

• Cumulative dose ≤ 240 mg/m² for conventional doxorubicin

• ≤ 140 mg/m² in case of prior doxorubicin and left chest radiotherapy (LCRT)

• Cumulative dose ≤ 400 mg/m² for epirubicin

• ≤ 230 mg/m² in case of prior epirubicin and LCRT