Prognostic and Predictive Factors for Small Breast Tumors

December 28, 2017 updated by: Andreas Pettersson, Karolinska Institutet

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

35002

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Solna, Sweden, 17177
        • Karolinska Instiutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with T1ab breast cancer.
Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
Radiotherapy versus no radiotherapy.
Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
Chemotherapy versus no chemotherapy.
Type of surgery (partial mastectomy, mastectomy, other).
Age at diagnosis (<35, 35-<50, 50-<70, ≥70).
Screening detected tumor (yes, no).
Menopausal status (premenopausal, postmenopausal).
Tumor size (≤5 mm, 6-≤10 mm).
ER-status (positive, negative).
Tumor grade (1, 2, 3).
HER2-status (positive, negative).
Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).
N-status (N0, N1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breast cancer specific death
Time Frame: January 1, 1977 to December 31, 2014
January 1, 1977 to December 31, 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from any cause
Time Frame: January 1, 1977 to July 30, 2016
January 1, 1977 to July 30, 2016
Metachronous breast cancer
Time Frame: January 1, 1977 to July 30, 2016
Ipsilateral or contralateral breast cancer
January 1, 1977 to July 30, 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1977

Primary Completion (Actual)

December 31, 2014

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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