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Title:
A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with ER Negative Early Stage Breast Cancer (PBI 3.0)
Protocol Number:
J13104
Phase:
Phase II
Physician:
Richard Zellars
Purpose:
PBI represents a treatment paradigm for the majority of women with early stage breast cancer. While the largest U.S. study has not yet matured other large European randomized trials and smaller U.S. single arm trials are reporting a higher rate of local failure in women with ER- breast cancer compared to women with ER breast cancer (12% vs. 2%). In contrast in our unique experience of treating women with PBI and concurrent chemotherapy we report a that women with ER- breast cancer had a 0% LF rate in one trial with med. 6 yr f/u and the same in a second trial with 3.5 yr. med. f/u. American Society of Therapeutic Radiation and Oncology guidelines recommend that women with ER- breast cancer should classified as cautious for treatment with PBI off trial. Additionally, concurrent chemotherapy and breast irradiation has been considered too toxic in the past and is currently rarely used except in the worst locally advanced cases, however in our previous experience it appears to be well tolerated. Given our experience, we hypothesize that PBI and concurrent chemotherapy 1) will be tolerable and 2)will result in superior local control in women with ER- tumors than the same treated with more standard PBI and sequential chemotherapy. To test these hypotheses we have designed this randomized trial of PBI and concurrent vs. sequential chemotherapy in women with ER- breast cancer.
Eligibility:
* female greater than 18 years of age * histologically confirmed (by routine H&E staining) ER-negative invasive adenocarcinoma of the breast * Patient must have undergone a segmental mastectomy (SM) * Patient must have a Medical Oncology consult and be recommended to receive one of the following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin and Trastuzamab (TCH) prior to registration. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the medical oncologist. * Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. * Patients must not have received prior radiation therapy to the involved breast at any time for any reason. * Patients must NOT have received any neo adjuvant chemotherapy or neo adjuvant hormonal therapy for the current cancer.
Treatment:
Population:
Adult
Last Update
07/30/2014 04:02 AM
 

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