ClinicalTrials.gg
CompletedNCT03390608Updated Jan 4, 2018

Prognostic and Predictive Factors for Small Breast Tumors

An observational study in Breast Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2018-01-04.

Sponsored by Karolinska Institutet · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
35,002
Ages
Up to 100 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Breast Neoplasms by Karolinska Institutet — 4 open to participants now, 6 under way, 2 of them phase 3. Breast Neoplasms · Karolinska Institutet.

Started
1977
the only one that year
Observational
Only one
of the 19
Registered
8th of 19
by date

Among the 19 studies in Breast Neoplasms by Karolinska Institutet, this one is the only one that started in 1977, is the only observational one, and was the 8th registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

4 of the 19 studies in Breast Neoplasms by Karolinska Institutet are open now, in 5 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: Up to 100 Years · female.

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02

Study 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.

03

Conditions studied

  • Breast Cancer

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04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Female
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Previous breast cancer.
  2. breast cancer at diagnosis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
35,002 participants (actual)
Patient registry
No

Groups and cohorts

  • Women with T1ab 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

Interventions

  • DrugEndocrine therapy

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

  • RadiationRadiotherapy

    Radiotherapy versus no radiotherapy.

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

  • DrugChemotherapy

    Chemotherapy versus no chemotherapy.

  • ProcedureType of breast cancer surgery

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

  • OtherAge at diagnosis

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

  • OtherScreen detected tumor

    Screening detected tumor (yes, no).

  • OtherMenopausal status at diagnosis

    Menopausal status (premenopausal, postmenopausal).

  • OtherTumor size

    Tumor size (≤5 mm, 6-≤10 mm).

  • OtherEstrogen receptor (ER) status

    ER-status (positive, negative).

  • OtherTumor grade

    Tumor grade (1, 2, 3).

  • OtherHER2-status

    HER2-status (positive, negative).

  • OtherIntrinsic subgroups of breast cancer

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

  • OtherNodal status

    N-status (N0, N1).

06

What researchers measure

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

    Ipsilateral or contralateral breast cancer

    Time frame: January 1, 1977 to July 30, 2016

07

Study locations

1 site
  • Karolinska Instiutet
    Solna, 17177, Sweden
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 1977 to primary completion in Dec 2014, 455 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2017
First posted
Jan 4, 2018
StartActual
Jan 1, 1977
Primary completionActual
Dec 31, 2014
CompletionActual
Jul 30, 2016
Last update
Jan 4, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03390608
Collaborators
The Swedish Society of Medicine, The Swedish Breast Cancer Association (BRO), Swedish Breast Cancer Group
Responsible party
Andreas Pettersson (Researcher, Principal Investigator, Karolinska Institutet) — Principal investigator
First posted
Jan 4, 2018
Start date
Jan 1, 1977
Primary completion
Dec 31, 2014
Completion
Jul 30, 2016
Last update
Jan 4, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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