Neoadjuvant ChemotherapyNCT06151379
Muscle Parameters and Pathological Response in Breast Cancer Patients
An observational study of Neoadjuvant Chemotherapy, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes. Read more about this study
- Who is it for?
- Ages 29 to 72 years, women only
- Conditions the study is for
- Neoadjuvant Chemotherapy
- What is being tested?
- Neoadjuvant therapy
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 20 Oct 2023
- 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 29 to 72 years
- Women only
- Adult, Older adult
Study population: Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.
Who may be able to join
- Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.
Who cannot join
- Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response
The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Read the detailed description
In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
- Conditions
- Neoadjuvant Chemotherapy
- Being tested
- Neoadjuvant therapy
- Keywords
- operable breast cancer, skeletal mass index, neoadjuvant chemotherapy, pathologic response, L3 vertebra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant therapyOther
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Pathologic complete response (pCR) | Patient with complete pathological response Receives: Other: Neoadjuvant therapy | |
| Pathologic incomplete response (non-pCR) | Patient with partial pathological response Receives: Other: Neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenic index
skeletal muscle area (cm2)/height (m2) et L3 level
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Body mass index
weight (kg)/height (m2)
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ChemotherapyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Yilmaz, Acıbadem Atunizade Hospital
- Investigators
- Aysun Isiklar, M.D., Principal investigator, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151379
- Sponsor's protocol ID
- AcıbademAH
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response
- ClinicalTrials.gov ID
- NCT06151379
- Acronym / sponsor ID
- AcıbademAH
- Conditions
- Neoadjuvant Chemotherapy
- Keywords
- operable breast cancer, skeletal mass index, neoadjuvant chemotherapy, pathologic response, L3 vertebra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 30 Nov 2023 (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.
The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Detailed description
In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathologic complete response (pCR) | – | Other: Neoadjuvant therapyPatient with complete pathological response |
| Pathologic incomplete response (non-pCR) | – | Other: Neoadjuvant therapyPatient with partial pathological response |
Who may qualify
- Ages
- 29 to 72 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.
Key inclusion criteria (1 listed)
- Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.
Key exclusion criteria (1 listed)
- Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.
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 |
|---|---|---|
| Neoadjuvant therapyTo measure muscle mass and predict pCR to NAC and its effect on clinical outcomes. | Other | Pathologic complete response (pCR), Pathologic incomplete response (non-pCR) |
Primary outcome
Sarcopenic index
Time frame: Through study completion, an average of 1 year.
skeletal muscle area (cm2)/height (m2) et L3 level
1 secondary outcome
Body mass index
Time frame: Through study completion, an average of 1 year.
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 30 Nov 2023.
- Individual participant dataSharing planned: No
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
Aysun Isiklar, M.D. principal investigator
Acıbadem Atunizade Hospital
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 Neoadjuvant Chemotherapy, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 30 Nov 2023. 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 Turkey (Türkiye). 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?
Sarcopenic index (time frame: Through study completion, an average of 1 year.). 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 30 Nov 2023.