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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
Sponsor:
Collaborators:
The Swedish Society of Medicine
The Swedish Breast Cancer Association (BRO)
Swedish Breast Cancer Group
Information provided by (Responsible Party):
Andreas Pettersson, Karolinska Institutet

Brief Summary:
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.

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

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Study Type : Observational
Actual Enrollment : 35002 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Women with T1ab breast cancer. Drug: Endocrine therapy
Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).

Radiation: Radiotherapy
Radiotherapy versus no radiotherapy.

Drug: Herceptin
Trastuzumab versus no trastuzumab (in women with HER2-positive disease).

Drug: Chemotherapy
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).

Other: HER2-status
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).




Primary Outcome Measures :
  1. Breast cancer specific death [ Time Frame: January 1, 1977 to December 31, 2014 ]

Secondary Outcome Measures :
  1. Death from any cause [ Time Frame: January 1, 1977 to July 30, 2016 ]
  2. Metachronous breast cancer [ Time Frame: January 1, 1977 to July 30, 2016 ]
    Ipsilateral or contralateral breast cancer



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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska Instiutet
Solna, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
The Swedish Society of Medicine
The Swedish Breast Cancer Association (BRO)
Swedish Breast Cancer Group
  Study Documents (Full-Text)

Documents provided by Andreas Pettersson, Karolinska Institutet:
Statistical Analysis Plan  [PDF] November 10, 2017
Study Protocol  [PDF] February 22, 2014


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Responsible Party: Andreas Pettersson, Researcher, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03390608     History of Changes
Other Study ID Numbers: 365
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Trastuzumab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents