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OpenTrials
Completed

NCT Number: NCT03390608

Prognostic and Predictive Factors for Small Breast Tumors

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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Key information

Age range

Up to 100 year

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska Instiutet

Solna, 17177, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female.
  • Operated for centimeter or subcentimeter breast cancer.

Exclusion criteria

  • Previous breast cancer.
  • Metastatic breast cancer at diagnosis.

Treatment and study plan

endocrine therapy

Drug

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

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).

Primary outcomes

  1. Breast cancer specific death

    Time frame: January 1, 1977 to December 31, 2014

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Swedish Breast Cancer Group
  • The Swedish Breast Cancer Association (BRO)
  • The Swedish Society of Medicine

Registry information

Official study title

Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer

Important dates

Study start
1977
Primary completion
2014
Study completion
2016
First posted
Jan 4, 2018
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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