In the US, breast cancer is the most common malignancy in women, accounting for approximately one fifth of cancer deaths in women. The treatment of breast cancer is directed towards the prevention of local recurrence by either mastectomy or by a lumpectomy followed by radiation therapy. The prevention of metastases is approached by either hormonal treatments, by combination chemotherapy regimens, or by a combination of the two. Local recurrence include tumor recurrences in the chest wall, the overlying skin, residual breast tissues, or lymph nodes. Approximately one third of patients with local recurrence after mastectomy have other concomitant metastases, and another 25% of patients develop other metastases shortly after the diagnosis of local failure. In constrast, local recurrence after breast conserving primary therapy are less frequently seen with concomitant distant metastases. the median survival for patients with isolated local recurrence is 2 to 3 years, and less than 10% are tumor free at 10 years. Local recurrence can represent residual disease that was inadequately treated with the primary therapy, but more often is a local manifestation of systemic disease. In the first case, it may be amenable to surgery or radiation therapy. In the later case a local as well as systemic treatment is required, either chemotherapy or hormonal therapy. Local excision is only applicable for patients with limited amounts of disease. Simple excision is a poor way of maintaining long-term local control, with more that 70% of women relapsing after excision. Radiation therapy is commonly used after excision. Initial complete tumor regression is seen in most patients, with complete remission rates ranging from 63% to 97%. However, 36% to 61% of women will experience further relapse in the radiation field, but are ineligible for more radiation therapy. These patients are the focus of this study. Current treatments for locally recurrent breast cancer are associated with significant morbidity, inadequate response rates, and frequent relapses. The purpose of this protocol is to evaluate if photodynamic therapy with Lutetium Texaphyrin (PCI-0123) Injection can result in significant responses in women who have failed radiation therapy to the chest wall for locally recurrent breast cancer, and if these responses translate into reduced symptoms for the chest wall reccurrences, and improve their quality of life.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000070-37S2
Application #
6219365
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
37
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Stanford University
Department
Type
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
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