Prognostic and Predictive Factors for Small Breast Tumors

Overview

Because of mammography screening increasingly more women are diagnosed with centimeter or subcentimeter node-negative breast cancer (i.e., T1abN0); these tumors account for approximately 19% of all newly diagnosed breast cancers in Sweden. Although the long term relapse-free survival rates among patients with such tumors is as high as ≥90%, some reports suggest that certain patient subgroups may have rates <75%. Firmly established prognostic and predictive factors for patients with T1abN0 tumors are, however, lacking. This is a nationwide, register-based cohort study investigating prognostic and predictive factors in women with centimeter or subcentimeter breast cancer. The study hypotheses are: 1) Established prognostic and/or predictive factors in overall breast cancer are prognostic and/or predictive factors also in centimeter or subcentimeter node-negative breast cancer; 2) The established relative reduction in risk of recurrence and death of adjuvant treatment for overall breast cancer are similar in centimeter or subcentimeter node-negative breast cancer.

Full Title of Study: “Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2014

Interventions

  • Drug: Endocrine therapy
    • Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
  • Radiation: Radiotherapy
    • Radiotherapy versus no radiotherapy.
  • Drug: Herceptin
    • Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
  • Drug: Chemotherapy
    • Chemotherapy versus no chemotherapy.
  • Procedure: Type of breast cancer surgery
    • Type of surgery (partial mastectomy, mastectomy, other).
  • Other: Age at diagnosis
    • Age at diagnosis (<35, 35-<50, 50-<70, ≥70).
  • Other: Screen detected tumor
    • Screening detected tumor (yes, no).
  • Other: Menopausal status at diagnosis
    • Menopausal status (premenopausal, postmenopausal).
  • Other: Tumor size
    • Tumor size (≤5 mm, 6-≤10 mm).
  • Other: Estrogen receptor (ER) status
    • ER-status (positive, negative).
  • Other: Tumor grade
    • Tumor grade (1, 2, 3).
  • Other: HER2-status
    • HER2-status (positive, negative).
  • Other: Intrinsic subgroups of breast cancer
    • Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).
  • Other: Nodal status
    • N-status (N0, N1).

Arms, Groups and Cohorts

  • Women with T1ab breast cancer.

Clinical Trial Outcome Measures

Primary Measures

  • Breast cancer specific death
    • Time Frame: January 1, 1977 to December 31, 2014

Secondary Measures

  • Death from any cause
    • Time Frame: January 1, 1977 to July 30, 2016
  • Metachronous breast cancer
    • Time Frame: January 1, 1977 to July 30, 2016
    • Ipsilateral or contralateral breast cancer

Participating in This Clinical Trial

Inclusion Criteria

1. Female. 2. Operated for centimeter or subcentimeter breast cancer. Exclusion Criteria:

1. Previous breast cancer. 2. Metastatic breast cancer at diagnosis.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: 100 Years

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • The Swedish Society of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andreas Pettersson, Researcher, Principal Investigator – Karolinska Institutet

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