5093S-11: S1007 breast

SWOG 1007: A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

Type of Study
Cancer (Oncology) - Breast
Location
Swedish Cancer Institute
Short Description

Purpose: This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Histologically confirmed invasive breast cancer meeting the following criteria:
    • 1-3 node-positive disease (pN1mi, pN1a, pN1b, or pN1c) by sentinel node biopsy or axillary lymph node dissection
      • Patients with positive sentinel node are not required to undergo full axillary lymph node dissection, at the discretion of the treating physician
    • Positive estrogen receptor (ER) and/or progesterone receptor (PR) status according to American Society of Clinical Research/College of American Pathologists (ASCO/CAP) guidelines
      • Considered positive if ≥ 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal [normal epithelial elements] and external controls
    • Negative HER-2 as determined by IHC or non-amplified fluorescence in situ hybridization (FISH) or chromogen in situ hybridization (CISH) for screening
      • If HER2 is 2+ by IHC, FISH/CISH must be performed and must not be positive (must be a ratio of ≤ 2.2)
      • If IHC is 0 or 1+ by institutional standards, FISH/CISH is not required
      • Patients with FISH/CISH in the indeterminate range (a ratio of 1.8 to 2.2) allowed provided they are not planning to receive treatment with trastuzumab
    • Recurrence Score (RS) by Oncotype DX® ≤ 25
      • Submission of tissue (paraffin block from primary tumor, positive and negative lymph node block) from surgery required
  • Patients with multifocal, multicentric, or synchronous bilateral breast cancers are allowed
    • Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant (The Oncotype DX® testing must be completed on the largest lesion)
    • Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (Oncotype DX® testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)
    • Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other (The Oncotype DX® testing should be completed on the node-positive breast)
  • Prior diagnosis of DCIS allowed provided it was treated with mastectomy alone (no therapeutic radiation or endocrine therapy)
  • No inflammatory breast cancer or metastatic disease
  • Must have had breast-conserving surgery with planned radiotherapy or total mastectomy (with or without planned postmastectomy radiation) with clear margins within the past 56 days
  • No prior chemotherapy or endocrine therapy for breast cancer
  • No prior preventive tamoxifen or raloxifene
  • No prior therapeutic breast radiotherapy
  • Not requiring concurrent chronic treatment with systemic steroids or other immunosuppressive agents
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org