Prognostic and Predictive Factors for Small Breast Tumors

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.

Conditions

• Breast Cancer

Interventions

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).

Sponsors & Collaborators

• The Swedish Society of Medicine

  collaborator OTHER

• The Swedish Breast Cancer Association (BRO)

  collaborator UNKNOWN

• Swedish Breast Cancer Group

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Eligibility

Max Age

100 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1977-01-01

Primary Completion

2014-12-31

Completion

2016-07-30

Countries

• Sweden

Study Locations