Inclusion Criteria:

1. Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):

   • Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible
   • Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
2. Tumor thickness, as measured by clinical exam or imaging studies (CT or MRI), must be less than 3 cm. The tumor surface must be able to be covered within two hyperthermia fields of treatment.

3. Subjects must have exhausted other available standard treatment options, including:

   • Mastectomy with standard adjuvant radiation, and/or adjuvant chemotherapy, and/or hormonal therapy
   • Chest wall radiation for non-resectable recurrent chest wall disease, (not administered less than 14 days prior to enrollment)
   • At least two conventional systemic chemotherapy regimens for recurrent disease such as capecitabine, taxane, or anthracycline (not administered less than 28 days prior to enrollment)
   • If HER2+, then treatment with trastuzumab and lapatinib (not administered less than 28 days prior to enrollment)
   • If ER+ (or PR+), then at least one course of hormonal therapy in the metastatic setting (not administered less than 28 days prior to enrollment).
4. Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.

5. Subjects may have distant metastasis, including brain metastasis. Subjects with known brain metastases are eligible if:

   • They have received standard antitumor treatment for their brain metastases as defined by the site's institutional standards.
   • Their neurological function is stable for at least 2 weeks prior to enrollment.
   • They are off steroid therapy or on a stable steroid regimen for 30 days prior to enrollment.
6. Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test prior to enrollment and must agree to practice an acceptable form of birth control while on the study.
7. Provide written informed consent and willing to comply with protocol requirements.

Exclusion Criteria:

1. Requires any concomitant antineoplastic therapy.
2. Prior sensitivity (including rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs.

3. Prior therapy with anthracyclines exceeding the following doses:

   Free (i.e., non-liposomal) doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.

4. Refractory pain secondary to metastatic disease.
5. Previous or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.

6. Baseline laboratories:

   • Granulocytes < 1,500/ microliter
   • Platelets < 75,000/ microliter
   • Hemoglobin < 9 gm/dL
   • Total Bilirubin > upper limit of normal
   • ALT and AST > 2.5 X upper limit of normal
   • Creatinine > 1.5 X upper limit of normal.
7. ECOG/Zubrod Performance Status > 2.
8. MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
9. Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

10. History of:

    1. Acute coronary syndrome
    2. Cerebral vascular accident
    3. Abnormal cardiac stress testing within last 6 months
    4. Symptomatic coronary artery disease
    5. Uncontrolled hypertension or cardiomyopathy
    6. Cardiac valvular surgery or open heart surgery
    7. Known structural heart disease.
11. Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
12. Known allergy to egg/egg products.
13. Active infection requiring treatment with IV antibiotics.
14. Has received any of the following medications within 14 days prior to enrollment: amphotericin B, antithyroid agents, azathioprine, chloramphenicol, colchicine, flucytosine, ganciclovir, interferon, plicamycin, zidovudine, probenecid, sulfinpyrazone, cyclosporine, phenobarbital, phenytoin, streptozocin or the administration of live viruses in immunocompromised patients.
15. Has received any external radiation therapy within 14 days prior to enrollment.