Prognostic and Predictive Factors for Small Breast Tumors

Completed

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

• Registration Number: NCT03390608
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1977-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2016-07-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35002

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with T1ab breast cancer.	Nodal status	-
Women with T1ab breast cancer.	Menopausal status at diagnosis	-
Women with T1ab breast cancer.	Tumor size	-
Women with T1ab breast cancer.	Estrogen receptor (ER) status	-
Women with T1ab breast cancer.	Tumor grade	-
Women with T1ab breast cancer.	HER2-status	-
Women with T1ab breast cancer.	Endocrine therapy	-
Women with T1ab breast cancer.	Radiotherapy	-
Women with T1ab breast cancer.	Herceptin	-
Women with T1ab breast cancer.	Chemotherapy	-
Women with T1ab breast cancer.	Intrinsic subgroups of breast cancer	-
Women with T1ab breast cancer.	Type of breast cancer surgery	-
Women with T1ab breast cancer.	Age at diagnosis	-
Women with T1ab breast cancer.	Screen detected tumor	-

Primary Outcome Measures

Name	Time	Method
Breast cancer specific death	January 1, 1977 to December 31, 2014

Secondary Outcome Measures

Name	Time	Method
Death from any cause	January 1, 1977 to July 30, 2016
Metachronous breast cancer	January 1, 1977 to July 30, 2016	Ipsilateral or contralateral breast cancer

Trial Locations

Locations (1)

Karolinska Instiutet; 🇸🇪 Solna, Sweden