- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03390608
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
Status
Completed
Conditions
Intervention / Treatment
- 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 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
-
-
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Solna, Sweden, 17177
- Karolinska Instiutet
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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:
- Female.
- Operated for centimeter or subcentimeter breast cancer.
Exclusion Criteria:
- Previous breast cancer.
- 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
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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
|
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Metachronous breast cancer
Time Frame: January 1, 1977 to July 30, 2016
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Ipsilateral or contralateral breast cancer
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January 1, 1977 to July 30, 2016
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 365
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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