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
Intervention: chemotherapy; radiation therapy
Intervention description: Given within 10 weeks after surgery.; Given within 6 months after surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive breast cancer

               -  First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph
                  node region) recurrence after primary treatment with mastectomy or
                  lumpectomy/quadrantectomy with clear surgical margins

                    -  Local failure is defined as a tumor recurrence in any soft tissue of the
                       ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin

                    -  Regional failure is defined as a tumor recurrence in the ipsilateral
                       axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla,
                       and/or ipsilateral internal mammary. Regional failure does not include
                       supraclavicular lymph nodes or tumor in the opposite breast

               -  No other prior recurrence in any site, including local

          -  Surgical resection of the recurrence meeting 1 of the following criteria:

               -  Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for
                  patients who had no prior adjuvant radiotherapy

               -  Mastectomy of the recurrence with uninvolved ("clear") margins after
                  lumpectomy/quadrantectomy alone for the primary

          -  Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are
             allowed for patients with HER-2 positive tumors and must be declared prior to
             randomization

          -  No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes,
             by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or
             bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically
             indicated (e.g., bone pain)

          -  No macroscopically incomplete surgery

          -  No bilateral malignancy except carcinoma in situ

          -  No suspicious mass in the opposite breast unless that mass has been proven by biopsy
             to be benign

          -  No skeletal pain of unknown cause

               -  No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI,
                  and/or CT scan

          -  Hormone receptor status:

               -  Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding
                  assay

               -  Estrogen receptor positive or negative

               -  Progesterone receptor positive or negative

        PATIENT CHARACTERISTICS:

        Age

          -  Minimum 18 years

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  No elevated alkaline phosphatase

        Renal

          -  Not specified

        Other

          -  Fertile patients must use effective non-hormonal contraception

          -  Medically suitable for chemotherapy of 3-6 months duration

          -  No other primary malignant tumors except adequately treated carcinoma in situ of the
             cervix or nonmelanoma skin cancer

          -  No non-malignant systemic disease that would preclude study treatment or prolong
             follow-up

          -  No psychiatric or addictive disorder that would preclude giving informed consent

          -  No history of noncompliance to medical regimens or potential for being unreliable

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  See Disease Characteristics