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| Name | Class |
|---|---|
| The Swedish Society of Medicine | OTHER |
| The Swedish Breast Cancer Association (BRO) | UNKNOWN |
| Swedish Breast Cancer Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with T1ab breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocrine therapy | Drug | Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer specific death | January 1, 1977 to December 31, 2014 |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | January 1, 1977 to July 30, 2016 | |
| Metachronous breast cancer | Ipsilateral or contralateral breast cancer | January 1, 1977 to July 30, 2016 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Instiutet | Solna | 17177 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2017 | Dec 15, 2017 |
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| Radiotherapy | Radiation | Radiotherapy versus no radiotherapy. |
|
| Herceptin | Drug | Trastuzumab versus no trastuzumab (in women with HER2-positive disease). |
|
| Chemotherapy | Drug | Chemotherapy versus no chemotherapy. |
|
| Type of breast cancer surgery | Procedure | Type of surgery (partial mastectomy, mastectomy, other). |
|
| Age at diagnosis | Other | Age at diagnosis (<35, 35-<50, 50-<70, ≥70). |
|
| Screen detected tumor | Other | Screening detected tumor (yes, no). |
|
| Menopausal status at diagnosis | Other | Menopausal status (premenopausal, postmenopausal). |
|
| Tumor size | Other | Tumor size (≤5 mm, 6-≤10 mm). |
|
| Estrogen receptor (ER) status | Other | ER-status (positive, negative). |
|
| Tumor grade | Other | Tumor grade (1, 2, 3). |
|
| HER2-status | Other | HER2-status (positive, negative). |
|
| Intrinsic subgroups of breast cancer | Other | Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative). |
|
| Nodal status | Other | N-status (N0, N1). |
|
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 22, 2014 | Dec 28, 2017 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000068878 | Trastuzumab |
| D004358 | Drug Therapy |
| D011960 | Receptors, Estrogen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011987 | Receptors, Steroid |
| D018160 | Receptors, Cytoplasmic and Nuclear |
| D014157 | Transcription Factors |
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