Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known whether chemotherapy is effective in treating
      women who have undergone surgery and radiation therapy for relapsed breast cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy
      in treating women who have undergone resection for local and/or regional relapsed breast
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in
           women with radically resected loco-regional relapsed breast cancer.

      Secondary

        -  Determine the systemic disease-free and overall survival of patients treated with this
           regimen.

        -  Determine the sites of recurrence, incidence of second (non-breast) malignancies, and
           causes of death without relapse of breast cancer in patients treated with this regimen.

        -  Determine the quality of life of patients treated with this regimen (QOL portion closed
           11/13/08).

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
      chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR)
      positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs
      regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive radiotherapy* within 6 months after surgery.

        -  Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an
           adjuvant chemotherapy regimen as determined by the investigator. Patients also receive
           radiotherapy* within 6 months after surgery and after the completion of chemotherapy OR
           integrated with chemotherapy.

      NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not
      required to receive further radiotherapy

      Patients with ER and/or PR positive tumors also receive standard hormonal therapy.

      Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed 11/13/08).

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.
    

Intervention name(s): chemotherapy; radiation therapy
Intervention type(s): Drug; Radiation
Intervention description(s): Given within 10 weeks after surgery.; Given within 6 months after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer