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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