Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

Lead Sponsor:

ETOP IBCSG Partners Foundation

Collaborating Sponsors:

NSABP Foundation Inc

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE3

Brief 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...

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 * Determi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 22 2016

    Estimated Enrollment :

    162 Patients enrolled

    Trial Details

    Trial ID

    NCT00074152

    Start Date

    July 1 2002

    End Date

    August 22 2016

    Last Update

    June 16 2017

    Active Locations (199)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 50 (199 locations)

    1

    Kaiser Permanente - Deer Valley

    Antioch, California, United States, 94531

    2

    Kaiser Permanente - Fremont

    Fremont, California, United States, 94538

    3

    Kaiser Permanente Medical Center - Hayward

    Hayward, California, United States, 94545

    4

    Kaiser Permanente Medical Center - Oakland

    Oakland, California, United States, 94611