Prognostic and Predictive Factors for Small Breast Tumors

NCT03390608 | Completed

• 1 other identifier: 365
• Study Type: observational
• Target: 35,002
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Breast cancer specific death

  January 1, 1977 to December 31, 2014

Secondary Outcomes (2)

• Death from any cause

  January 1, 1977 to July 30, 2016

• Metachronous breast cancer

  January 1, 1977 to July 30, 2016

Study Arms (1)

Women with T1ab breast cancer.

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

Interventions

Endocrine therapy DRUG

Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).

Women with T1ab breast cancer.

Radiotherapy RADIATION

Radiotherapy versus no radiotherapy.

Women with T1ab breast cancer.

Herceptin DRUG

Trastuzumab versus no trastuzumab (in women with HER2-positive disease).

Women with T1ab breast cancer.

Chemotherapy DRUG

Chemotherapy versus no chemotherapy.

Women with T1ab breast cancer.

Type of breast cancer surgery PROCEDURE

Type of surgery (partial mastectomy, mastectomy, other).

Women with T1ab breast cancer.

Age at diagnosis OTHER

Age at diagnosis (\<35, 35-\<50, 50-\<70, ≥70).

Women with T1ab breast cancer.

Screen detected tumor OTHER

Screening detected tumor (yes, no).

Women with T1ab breast cancer.

Menopausal status at diagnosis OTHER

Menopausal status (premenopausal, postmenopausal).

Women with T1ab breast cancer.

Tumor size OTHER

Tumor size (≤5 mm, 6-≤10 mm).

Women with T1ab breast cancer.

Estrogen receptor (ER) status OTHER

ER-status (positive, negative).

Women with T1ab breast cancer.

Tumor grade OTHER

Tumor grade (1, 2, 3).

Women with T1ab breast cancer.

HER2-status OTHER

HER2-status (positive, negative).

Women with T1ab breast cancer.

Intrinsic subgroups of breast cancer OTHER

Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).

Women with T1ab breast cancer.

Nodal status OTHER

N-status (N0, N1).

Women with T1ab breast cancer.

Eligibility Criteria

• Age: Up to 100 Years
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all Swedish women operated for centimeter or subcentimeter breast cancer who are included in the regional breast cancer registries (1977 to 2007) or the national breast cancer registry (2008 onwards).

You may qualify if:

• Female.
• Operated for centimeter or subcentimeter breast cancer.

You may not qualify if:

• Previous breast cancer.
• Metastatic breast cancer at diagnosis.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Society of Medicine: collaborator
• The Swedish Breast Cancer Association (BRO): collaborator
• Swedish Breast Cancer Group: collaborator

Study Sites (1)

Karolinska Instiutet

Solna, 17177, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy; Trastuzumab; Drug Therapy; Receptors, Estrogen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Receptors, Steroid; Receptors, Cytoplasmic and Nuclear; Transcription Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Principal Investigator

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 4, 2018
• Study Start: January 1, 1977
• Primary Completion: December 31, 2014
• Study Completion: July 30, 2016
• Last Updated: January 4, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)