Prognostic and Predictive Factors for Small Breast Tumors

NCT ID: NCT03390608

Last Updated: 2018-01-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

35002 participants

Study Classification

OBSERVATIONAL

Study Start Date

1977-01-01

Study Completion Date

2016-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women with T1ab breast cancer.

Endocrine therapy

Intervention Type DRUG

Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).

Radiotherapy

Intervention Type RADIATION

Radiotherapy versus no radiotherapy.

Herceptin

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Chemotherapy versus no chemotherapy.

Type of breast cancer surgery

Intervention Type PROCEDURE

Type of surgery (partial mastectomy, mastectomy, other).

Age at diagnosis

Intervention Type OTHER

Age at diagnosis (\<35, 35-\<50, 50-\<70, ≥70).

Screen detected tumor

Intervention Type OTHER

Screening detected tumor (yes, no).

Menopausal status at diagnosis

Intervention Type OTHER

Menopausal status (premenopausal, postmenopausal).

Tumor size

Intervention Type OTHER

Tumor size (≤5 mm, 6-≤10 mm).

Estrogen receptor (ER) status

Intervention Type OTHER

ER-status (positive, negative).

Tumor grade

Intervention Type OTHER

Tumor grade (1, 2, 3).

HER2-status

Intervention Type OTHER

HER2-status (positive, negative).

Intrinsic subgroups of breast cancer

Intervention Type OTHER

Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).

Nodal status

Intervention Type OTHER

N-status (N0, N1).

Interventions

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Endocrine therapy

Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).

Intervention Type DRUG

Radiotherapy

Radiotherapy versus no radiotherapy.

Intervention Type RADIATION

Herceptin

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

Intervention Type DRUG

Chemotherapy

Chemotherapy versus no chemotherapy.

Intervention Type DRUG

Type of breast cancer surgery

Type of surgery (partial mastectomy, mastectomy, other).

Intervention Type PROCEDURE

Age at diagnosis

Age at diagnosis (\<35, 35-\<50, 50-\<70, ≥70).

Intervention Type OTHER

Screen detected tumor

Screening detected tumor (yes, no).

Intervention Type OTHER

Menopausal status at diagnosis

Menopausal status (premenopausal, postmenopausal).

Intervention Type OTHER

Tumor size

Tumor size (≤5 mm, 6-≤10 mm).

Intervention Type OTHER

Estrogen receptor (ER) status

ER-status (positive, negative).

Intervention Type OTHER

Tumor grade

Tumor grade (1, 2, 3).

Intervention Type OTHER

HER2-status

HER2-status (positive, negative).

Intervention Type 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).

Intervention Type OTHER

Nodal status

N-status (N0, N1).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Previous breast cancer.
2. Metastatic breast cancer at diagnosis.
Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Society of Medicine

OTHER

Sponsor Role collaborator

The Swedish Breast Cancer Association (BRO)

UNKNOWN

Sponsor Role collaborator

Swedish Breast Cancer Group

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Andreas Pettersson

Researcher, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Instiutet

Solna, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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365

Identifier Type: -

Identifier Source: org_study_id

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