Prognostic and Predictive Factors for Small Breast Tumors
NCT ID: NCT03390608
Last Updated: 2018-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35002 participants
OBSERVATIONAL
1977-01-01
2016-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Women with T1ab breast cancer.
Endocrine therapy
Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
Radiotherapy
Radiotherapy versus no radiotherapy.
Herceptin
Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
Chemotherapy
Chemotherapy versus no chemotherapy.
Type of breast cancer surgery
Type of surgery (partial mastectomy, mastectomy, 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).
Interventions
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Endocrine therapy
Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
Radiotherapy
Radiotherapy versus no radiotherapy.
Herceptin
Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
Chemotherapy
Chemotherapy versus no chemotherapy.
Type of breast cancer surgery
Type of surgery (partial mastectomy, mastectomy, 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).
Eligibility Criteria
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Inclusion Criteria
2. Operated for centimeter or subcentimeter breast cancer.
Exclusion Criteria
2. Metastatic breast cancer at diagnosis.
100 Years
FEMALE
No
Sponsors
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The Swedish Society of Medicine
OTHER
The Swedish Breast Cancer Association (BRO)
UNKNOWN
Swedish Breast Cancer Group
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Andreas Pettersson
Researcher, Principal Investigator
Locations
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Karolinska Instiutet
Solna, , Sweden
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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365
Identifier Type: -
Identifier Source: org_study_id
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