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Prognostic and Predictive Factors for Small Breast Tumors

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03390608
Collaborator
The Swedish Society of Medicine (Other), The Swedish Breast Cancer Association (BRO) (Other), Swedish Breast Cancer Group (Other)
35,002
Enrollment
1
Location
474.9
Actual Duration (Months)
73.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Observational
Actual Enrollment :
35002 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer
Actual Study Start Date :
Jan 1, 1977
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Jul 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Women with T1ab breast cancer.

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).

Outcome Measures

Primary Outcome Measures

  1. Breast cancer specific death [January 1, 1977 to December 31, 2014]

Secondary Outcome Measures

  1. Death from any cause [January 1, 1977 to July 30, 2016]

  2. Metachronous breast cancer [January 1, 1977 to July 30, 2016]

    Ipsilateral or contralateral breast cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 100 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

  1. Female.

  2. Operated for centimeter or subcentimeter breast cancer.

Exclusion Criteria:

  1. Previous breast cancer.

  2. Metastatic breast cancer at diagnosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Instiutet Solna Sweden 17177

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Andreas Pettersson, Researcher, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03390608
Other Study ID Numbers:
  • 365
First Posted:
Jan 4, 2018
Last Update Posted:
Jan 4, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Trastuzumab
Estrogens

Study Results

No Results Posted as of Jan 4, 2018