Prognostic and Predictive Factors for Small Breast Tumors
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|ClinicalTrials.gov Identifier: NCT03390608|
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer||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|
|Actual Enrollment :||35002 participants|
|Official Title:||Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer|
|Actual Study Start Date :||January 1, 1977|
|Actual Primary Completion Date :||December 31, 2014|
|Actual Study Completion Date :||July 30, 2016|
|Women with T1ab breast cancer.||
Drug: Endocrine therapy
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.
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).
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).
- Breast cancer specific death [ Time Frame: January 1, 1977 to December 31, 2014 ]
- Death from any cause [ Time Frame: January 1, 1977 to July 30, 2016 ]
- Metachronous breast cancer [ Time Frame: January 1, 1977 to July 30, 2016 ]Ipsilateral or contralateral breast cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390608
|Solna, Sweden, 17177|