Reirradiation With Concurrent Paclitaxel for Breast Cancer

Inclusion Criteria:

- Pathologically proven diagnosis of breast cancer with clinical evidence of recurrent
disease on the chest wall following treatment that included radiotherapy, and for
which there is no current standard of care or curative resection able to be performed

- Patients are permitted to have received prior therapy, but must have received a
minimum of 30 Gy to the chest wall with a minimal interval since completion of
radiation therapy equal to or greater than 6 months.

- Patients are permitted to have been treated with previous systemic chemotherapy. A
minimal time interval since last dose of cytotoxic chemotherapy must be equal to or
greater than 21 days, and all acute toxicities should be resolved to less than grade
2, and hematologic counts should meet study criteria. With regards to toxicity,
patients who have left sided chest wall recurrences should not have previously
exceeded more than 450 mg/m2 doxorubicin due to expected cumulative cardiotoxicity.
Prior taxane therapy is allowed, however, there should be no reported anaphylactic
reactions of grade 3 or higher.

- Age ≥18 years

- ECOG performance status ≤2

- Life expectancy of greater than 3 months

- Normal organ and marrow function as defined below:

- absolute neutrophil count ≥1,500/mcL

- platelets ≥100,000/mcL

- total bilirubin < 1.5 x institutional upper limit of normal

- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

- creatinine within normal institutional limits OR creatinine clearance ≥60
mL/min/1.73 m2 for patients with creatinine

- levels above institutional normal

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients who have had radiotherapy within 6 months prior to entering the study or
those who have not recovered to < grade 2 adverse events due to radiation

- Patients who have experienced a previous grade 3 or 4 anaphylactic reaction to
Paclitaxel.

- Patients with grade > 2 neuropathy attributable to previous administration of Taxane
chemotherapy.

- Patients who have received prior chemotherapy are allowed, provided they have been
off systemic therapy for 21 days and all acute toxicities have resolved to less than
grade 2. Patients who have received Paclitaxel within 3 months of study entry and
have developed documented progressive disease despite therapy.

- Patients who are receiving any other investigational agents

- Patients with known brain metastases should have their brain metastases treated prior
to enrollment on this protocol. Subjects may enroll on this trial after completion of
whole brain radiation therapy and/or Stereotactic Radiosurgery, provided they are
clinically without evidence of progressive brain metastases.

- Patient who are actively receiving other cytotoxic or antibiologic chemotherapies.
For patients with Her-2/neu positive disease, Trastuzumab (Herceptin) is NOT ALLOWED
on this study, and should be withheld during the 8 weeks of therapy, and can be
resumed no sooner than 14 days following completion of protocol therapy

- Women with a confirmed intrauterine pregnancy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study because Paclitaxel is an antimicrotubule
agent with known potential for teratogenic or abortifacient effects. Because there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with Paclitaxel, breastfeeding should be discontinued if the
mother is treated with Paclitaxel

- HIV-positive patients on combination antiretroviral therapy are ineligible.

- Patients with poor cardiac function defined as an ejection fraction (EF) < 40% are
excluded.