A Phase I/II Study Evaluating the Maximum Tolerated Dose, Bioequivalence/Pharmacokinetics, Safety, and Efficacy of Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Local-Regional Recurrent Breast Cancer.

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.

- Breast carcinoma for medical reasons not being resected

2. Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by
clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must
be able to be covered within two hyperthermia fields of treatment.

3. Disease that has progressed despite other available standard treatment options, based
on what is clinically indicated according to the investigator's clinical and medical
judgment, including:

- One or more radiation treatment(s) to the chest wall or breast up to a maximum
prior dose of 12,000 cGy in the hyperthermia field (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 metastases. Subjects with known
brain metastases are eligible if:

- They have received standard anti-tumor treatment for their brain metastases
without encephalopathy;

- Their neurological function is stable for at least 30 days and either off
steroid therapy or on a stable steroid regimen.

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 at baseline 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. Subjects on a current stable dose of
hormonal treatments may continue on a stable dose during the study (i.e. arimidex,
amarosin, herceptin).

2. Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing,
urticaria or other symptoms) attributed to the administration of either
anthracyclines or other liposomally encapsulated drugs that required discontinuation
of prior therapy.

3. Prior therapy with anthracyclines exceeding the following doses (subjects will be
discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox®
cycles received):

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

4. Previous (required active treatment within 5 years) 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.

5. Baseline laboratories (repeat labs can be evaluated at baseline to establish
eligibility:

- ANC Granulocytes < 1,500/ microliter

- Platelets < 75,000/ microliter

- Hemoglobin < 9 gm/dL

- Total Bilirubin > 2 mg/dL

- ALT and AST > 2.5 X upper limit of normal

- Creatinine > 1.5 X upper limit of normal.

6. ECOG/Zubrod Performance Status > 2.

7. MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.

8. 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.

9. History of:

- Acute coronary syndrome

- Cerebral vascular accident

- Abnormal cardiac stress testing within last 6 months

- Symptomatic coronary artery disease

- Uncontrolled hypertension or cardiomyopathy

- Cardiac valvular surgery or open heart surgery

- Known structural heart disease.

10. 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, breast reconstruction with implants, severe numbness and/or tingling of the
chest wall or breast, skin grafts and/or flaps on the breast or chest wall.

11. Active infection requiring antibiotic treatment

12. Has received any external radiation therapy within 28 days prior to enrollment.