Breast CancerNCT07630558
Investigation of the Prognostic Value of Patterns of Genomic Alterations or Protein Expression in Patients With Operated Early Breast Cancer
An observational study of Breast Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
This study retrospectively analyze tumor samples and clinical data from Greek women with operable breast cancer of intermediate or high-risk of relapse who participated in HeCOG adjuvant studies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,891 participants
- Where
- 1 siteGreece
- Study dates
- 31 Jan 1997to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study includes tumors from patients with operable breast cancer of intermediate or high risk of relapse, according to St.Gallen criteria, treated with dose-dense sequential adjuvant chemotherapy with epirubicin, cyclophosphamide, taxane (only a certain group did not include a taxane) and "intensified" CMF.
Who may be able to join
- Women with histologically confirmed epithelial breast cancer
- Age >18 years
- Pathological stage
- Eastern Cooperative Oncology Group performance status 0-1
- Normal cardiac function and adequate bone marrow, hepatic and renal function.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study retrospectively analyze tumor samples and clinical data from Greek women with operable breast cancer of intermediate or high-risk of relapse who participated in HeCOG adjuvant studies. Patients were treated with dose-dense sequential adjuvant chemotherapy regimens mainly including epirubicin, cyclophosphamide, taxanes, and "intensified" CMF.
The main goal is to investigate how tumor characteristics and genetic mutations relate to breast cancer subtype and patient outcome (OS). Tumor samples were centrally reviewed using immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and next-generation sequencing (NGS). Tumors were classified into molecular subtypes such as: Luminal A, Luminal B, Luminal-HER2, HER2-enriched and Triple-negative.
Read more
Important biomarkers analyzed included: ER (estrogen receptor), PgR (progesterone receptor), HER2, Ki67 (cell proliferation marker), EGFR and CK5 (basal-like markers), CD8-positive tumor infiltrating lymphocytes (immune response marker) as well as recurrent alterations in genes commonly mutated in breast cancer including among others TP53, PIK3CA, GATA3, CDH1, PTEN and AKT1. HER2 and TOP2A gene amplification were assessed using FISH.
Tumor immune infiltration (TILs) was also evaluated by expert pathologists. DNA extracted from archived tumor tissue was analyzed with a custom breast cancer NGS panel targeting genes commonly mutated in breast cancer.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Patients who received adjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Time from study entry to death from any cause up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start31 Jan 1997
- Primary completion31 Jan 2008
- Study completion15 Oct 2026 (estimated)
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.
- 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
- 1,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630558
- Sponsor's protocol ID
- TRANS_G_BR/23
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Prognostic Value of Patterns of Genomic Alterations or Protein Expression in Patients With Operated Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07630558
- Acronym / sponsor ID
- TRANS_G_BR/23
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,891 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 31 Jan 1997 (actual)
- Primary completion
- 31 Jan 2008 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Jun 2026 (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.
This study retrospectively analyze tumor samples and clinical data from Greek women with operable breast cancer of intermediate or high-risk of relapse who participated in HeCOG adjuvant studies. Patients were treated with dose-dense sequential adjuvant chemotherapy regimens mainly including epirubicin, cyclophosphamide, taxanes, and "intensified" CMF.
The main goal is to investigate how tumor characteristics and genetic mutations relate to breast cancer subtype and patient outcome (OS). Tumor samples were centrally reviewed using immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and next-generation sequencing (NGS). Tumors were classified into molecular subtypes such as: Luminal A, Luminal B, Luminal-HER2, HER2-enriched and Triple-negative.
Important biomarkers analyzed included: ER (estrogen receptor), PgR (progesterone receptor), HER2, Ki67 (cell proliferation marker), EGFR and CK5 (basal-like markers), CD8-positive tumor infiltrating lymphocytes (immune response marker) as well as recurrent alterations in genes commonly mutated in breast cancer including among others TP53, PIK3CA, GATA3, CDH1, PTEN and AKT1. HER2 and TOP2A gene amplification were assessed using FISH.
Tumor immune infiltration (TILs) was also evaluated by expert pathologists. DNA extracted from archived tumor tissue was analyzed with a custom breast cancer NGS panel targeting genes commonly mutated in breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | – | –Patients who received adjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes tumors from patients with operable breast cancer of intermediate or high risk of relapse, according to St.Gallen criteria, treated with dose-dense sequential adjuvant chemotherapy with epirubicin, cyclophosphamide, taxane (only a certain group did not include a taxane) and "intensified" CMF.
Key inclusion criteria (5 listed)
- Women with histologically confirmed epithelial breast cancer
- Age >18 years
- Pathological stage
- Eastern Cooperative Oncology Group performance status 0-1
- Normal cardiac function and adequate bone marrow, hepatic and renal function.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Time from study entry to death from any cause up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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 Hellenic Cooperative Oncology Group at 1 site in Greece.
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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: Time from study entry to death from any cause up to 120 months). 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 5 Jun 2026.