Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-01-18
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Metastatic or recurrent disease

• Considered incurable

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Two primary breast cancers allowed

• Paraffin-embedded primary or metastatic tumor sample available

• No known brain metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active uncontrolled infection

• No upper gastrointestinal condition or other condition that would preclude ability to take oral medication

• No other serious medical condition that would preclude study participation

• No psychiatric illness or neurologic disorder that would preclude study compliance

• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder

PRIOR CONCURRENT THERAPY:

Chemotherapy

• At least 4 weeks since prior chemotherapy

• Prior adjuvant chemotherapy allowed

• No more than 1 prior chemotherapy regimen for metastatic or recurrent disease

Endocrine therapy

• At least 5 days since prior hormonal therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction, palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to < 20% of functioning bone marrow

• If prior radiotherapy was to sole site of disease, must have subsequent documented disease progression at that site

Surgery

• At least 3 weeks since prior major surgery

Other

• Concurrent prophylactic bisphosphonates allowed, if started prior to study entry

• No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem, or ketoconazole and similar antifungals

• No other concurrent anticancer therapy

• No other concurrent investigational agents

• No concurrent grapefruit juice