Breast CancerNCT03390608
Prognostic and Predictive Factors for Small Breast Tumors
An observational study of Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Endocrine therapy, Radiotherapy and Herceptin
- Type of treatment
- Surgery or procedure
- How many people
- 35,002 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 1977to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Women only
- Child, Adult, Older adult
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).
Who may be able to join
- Female.
- Operated for centimeter or subcentimeter breast cancer.
Who cannot join
- Previous breast cancer.
- Metastatic breast cancer at diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer
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
- Being tested
- Endocrine therapy, Radiotherapy, Herceptin, Chemotherapy, Type of breast cancer surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine therapyDrug
Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
RadiotherapyRadiation
Radiotherapy versus no radiotherapy.
HerceptinDrug
Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
ChemotherapyDrug
Chemotherapy versus no chemotherapy.
Type of breast cancer surgeryProcedure or surgery
Type of surgery (partial mastectomy, mastectomy, other).
Age at diagnosisOther
Age at diagnosis (<35, 35-<50, 50-<70, ≥70).
Screen detected tumorOther
Screening detected tumor (yes, no).
Menopausal status at diagnosisOther
Menopausal status (premenopausal, postmenopausal).
Tumor sizeOther
Tumor size (≤5 mm, 6-≤10 mm).
Estrogen receptor (ER) statusOther
ER-status (positive, negative).
Tumor gradeOther
Tumor grade (1, 2, 3).
HER2-statusOther
HER2-status (positive, negative).
Intrinsic subgroups of breast cancerOther
Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).
Nodal statusOther
N-status (N0, N1).
| Study group | Role | What they receive |
|---|---|---|
| Women with T1ab breast cancer. | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer specific death
Measured: January 1, 1977 to December 31, 2014
Secondary outcomes (2)
Death from any cause
Measured: January 1, 1977 to July 30, 2016
Metachronous breast cancer
Ipsilateral or contralateral breast cancer
Measured: January 1, 1977 to July 30, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Jan 1977
- Primary completion31 Dec 2014
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Society of Medicine, The Swedish Breast Cancer Association (BRO), Swedish Breast Cancer Group
- Responsible party
- Principal investigator, Andreas Pettersson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390608
- Sponsor's protocol ID
- 365
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03390608
- Acronym / sponsor ID
- 365
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,002 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Society of Medicine, The Swedish Breast Cancer Association (BRO), Swedish Breast Cancer Group
- Study start
- 1 Jan 1977 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 100 years
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Female.
- Operated for centimeter or subcentimeter breast cancer.
Key exclusion criteria (2 listed)
- Previous breast cancer.
- Metastatic breast cancer at diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocrine therapyEndocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease). | Drug | Women with T1ab breast cancer. |
| RadiotherapyRadiotherapy versus no radiotherapy. | Radiation | Women with T1ab breast cancer. |
| HerceptinTrastuzumab versus no trastuzumab (in women with HER2-positive disease). | Drug | Women with T1ab breast cancer. |
| ChemotherapyChemotherapy versus no chemotherapy. | Drug | Women with T1ab breast cancer. |
| Type of breast cancer surgeryType of surgery (partial mastectomy, mastectomy, other). | Procedure or surgery | Women with T1ab breast cancer. |
| Age at diagnosisAge at diagnosis (<35, 35-<50, 50-<70, ≥70). | Other | Women with T1ab breast cancer. |
| Screen detected tumorScreening detected tumor (yes, no). | Other | Women with T1ab breast cancer. |
| Menopausal status at diagnosisMenopausal status (premenopausal, postmenopausal). | Other | Women with T1ab breast cancer. |
| Tumor sizeTumor size (≤5 mm, 6-≤10 mm). | Other | Women with T1ab breast cancer. |
| Estrogen receptor (ER) statusER-status (positive, negative). | Other | Women with T1ab breast cancer. |
| Tumor gradeTumor grade (1, 2, 3). | Other | Women with T1ab breast cancer. |
| HER2-statusHER2-status (positive, negative). | Other | Women with T1ab breast cancer. |
| Intrinsic subgroups of breast cancerIntrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative). | Other | Women with T1ab breast cancer. |
| Nodal statusN-status (N0, N1). | Other | Women with T1ab breast cancer. |
Primary outcome
Breast cancer specific death
Time frame: January 1, 1977 to December 31, 2014
2 secondary outcomes
Death from any cause
Time frame: January 1, 1977 to July 30, 2016
Metachronous breast cancer
Time frame: January 1, 1977 to July 30, 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer specific death (time frame: January 1, 1977 to December 31, 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.