Triple-Negative Breast Cancer (TNBC)ReS-TNBCNCT07714382
Survival Outcomes of Residual Disease in Triple-Negative Breast Cancer
An observational study of Triple-Negative Breast Cancer (TNBC), run by Sohag University at 1 site in Egypt.
Trial summary
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with a poor prognosis. Although neoadjuvant therapy improves outcomes in patients who achieve a pathological complete response, the presence of residual disease after treatment remains associated with an increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- Chemo-radiotherapy alone and Not applicable- observational study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Jul 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult female patients with histologically confirmed triple-negative breast cancer (TNBC) who received neoadjuvant systemic therapy followed by definitive surgery and were treated at the study institution during the study period. Data will be collected retrospectively from medical records to evaluate the association between residual disease after neoadjuvant therapy and survival outcomes.
Who may be able to join
- Female patients aged ≥18 years. Histologically confirmed triple-negative breast cancer (TNBC). Received standard neoadjuvant systemic therapy. Underwent definitive breast surgery after completion of neoadjuvant therapy. Availability of postoperative pathological assessment documenting residual disease or pathological complete response (pCR).
- Complete clinical, pathological, treatment, and follow-up data available in the medical records.
Who cannot join
- Patients with metastatic disease at initial diagnosis. Patients who did not complete neoadjuvant therapy or did not undergo definitive surgery.
- Patients with incomplete or missing essential clinical, pathological, or follow-up data.
- Patients with a history of another primary malignancy that could affect survival analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Outcomes of Residual Disease in Patients With Triple-Negative Breast Cancer Following Neoadjuvant Therapy: A Retrospective Cohort Study
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with a poor prognosis. Although neoadjuvant therapy improves outcomes in patients who achieve a pathological complete response, the presence of residual disease after treatment remains associated with an increased risk of recurrence and death. This retrospective cohort study aims to evaluate the survival outcomes of patients with residual disease following neoadjuvant therapy for TNBC and to assess the association between clinicopathological characteristics and survival outcomes, including disease-free survival and overall survival
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- Chemo-radiotherapy alone, Not applicable- observational study
- Keywords
- Triple-Negative Breast Cancer (TNBC)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo-radiotherapy aloneProcedure or surgery
Chemo and radiotherapy before surgery
Not applicable- observational studyOther
Not applicable. This is a retrospective observational cohort study. No study intervention is administered. Data will be collected retrospectively from patients' medical records, and all treatments were provided as part of routine clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 May 2026
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelfattah Kassem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714382
- Sponsor's protocol ID
- TNBC-RD-2026-001
- Acronym
- ReS-TNBC
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes of Residual Disease in Patients With Triple-Negative Breast Cancer Following Neoadjuvant Therapy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07714382
- Acronym / sponsor ID
- ReS-TNBC / TNBC-RD-2026-001
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Keywords
- Triple-Negative Breast Cancer (TNBC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Jul 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.
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with a poor prognosis. Although neoadjuvant therapy improves outcomes in patients who achieve a pathological complete response, the presence of residual disease after treatment remains associated with an increased risk of recurrence and death. This retrospective cohort study aims to evaluate the survival outcomes of patients with residual disease following neoadjuvant therapy for TNBC and to assess the association between clinicopathological characteristics and survival outcomes, including disease-free survival and overall survival
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with histologically confirmed triple-negative breast cancer (TNBC) who received neoadjuvant systemic therapy followed by definitive surgery and were treated at the study institution during the study period. Data will be collected retrospectively from medical records to evaluate the association between residual disease after neoadjuvant therapy and survival outcomes.
Key inclusion criteria (2 listed)
- Female patients aged ≥18 years. Histologically confirmed triple-negative breast cancer (TNBC). Received standard neoadjuvant systemic therapy. Underwent definitive breast surgery after completion of neoadjuvant therapy. Availability of postoperative pathological assessment documenting residual disease or pathological complete response (pCR).
- Complete clinical, pathological, treatment, and follow-up data available in the medical records.
Key exclusion criteria (3 listed)
- Patients with metastatic disease at initial diagnosis. Patients who did not complete neoadjuvant therapy or did not undergo definitive surgery.
- Patients with incomplete or missing essential clinical, pathological, or follow-up data.
- Patients with a history of another primary malignancy that could affect survival analysis.
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 |
|---|---|---|
| Chemo-radiotherapy aloneChemo and radiotherapy before surgery | Procedure or surgery | – |
| Not applicable- observational studyNot applicable. This is a retrospective observational cohort study. No study intervention is administered. Data will be collected retrospectively from patients' medical records, and all treatments were provided as part of routine clinical care. | Other | – |
Primary outcome
Disease free survival
Time frame: Up to 3 years
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 20 Jul 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 Triple-Negative Breast Cancer (TNBC), run by Sohag University at 1 site in Egypt.
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 3 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 20 Jul 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 Egypt. 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?
Disease free survival (time frame: Up to 3 years). 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 20 Jul 2026.