Prognostic and Predictive Factors for Small Breast Tumors

Karolinska Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Type of breast cancer surgery; Other: HER2-status; Other: Screen detected tumor; Drug: Chemotherapy; Drug: Endocrine therapy; Drug: Herceptin; Other: Nodal status; Other: Tumor grade; Other: Estrogen receptor (ER) status; Other: Intrinsic subgroups of breast cancer; Other: Tumor size; Other: Age at diagnosis; Radiation: Radiotherapy; Other: Menopausal status at diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT03390608

365

Details and patient eligibility

About

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.

Enrollment: 35,002 patients

Sex: Female

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female.
2. Operated for centimeter or subcentimeter breast cancer.

Exclusion criteria

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

Trial design

35,002 participants in 1 patient group

Women with T1ab breast cancer.

Treatment:

Other: Estrogen receptor (ER) status

Other: Intrinsic subgroups of breast cancer

Radiation: Radiotherapy

Other: HER2-status

Other: Menopausal status at diagnosis

Procedure: Type of breast cancer surgery

Drug: Chemotherapy

Other: Nodal status

Other: Screen detected tumor

Drug: Herceptin

Drug: Endocrine therapy

Other: Tumor size

Other: Age at diagnosis

Other: Tumor grade