Prognostic and Predictive Factors for Small Breast Tumors

Breast Cancer Clinical Trial

Official title:

Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390608
• Other study ID #: 365
• Status: Completed
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 28, 2017
• Start date: January 1, 1977
• Est. completion date: July 30, 2016

Study information

• Verified date: December 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35002
• Est. completion date: July 30, 2016
• Est. primary completion date: December 31, 2014
• Gender: Female
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

1. Female.

2. Operated for centimeter or subcentimeter breast cancer.

Exclusion Criteria:

1. Previous breast cancer.

2. Metastatic breast cancer at diagnosis.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).
• 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).
• Screen detected tumor
Screening detected tumor (yes, no).
• Menopausal status at diagnosis
Menopausal status (premenopausal, postmenopausal).
• Tumor size
Tumor size (=5 mm, 6-=10 mm).
• Estrogen receptor (ER) status
ER-status (positive, negative).
• Tumor grade
Tumor grade (1, 2, 3).
• HER2-status
HER2-status (positive, negative).
• Intrinsic subgroups of breast cancer
Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).
• Nodal status
N-status (N0, N1).

Locations

Country	Name	City	State
Sweden	Karolinska Instiutet	Solna

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Breast Cancer Group, The Swedish Breast Cancer Association (BRO), The Swedish Society of Medicine

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer specific death		January 1, 1977 to December 31, 2014
Secondary	Death from any cause		January 1, 1977 to July 30, 2016
Secondary	Metachronous breast cancer	Ipsilateral or contralateral breast cancer	January 1, 1977 to July 30, 2016