NCT06151379

Brief Summary

The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 4, 2023

Last Update Submit

November 21, 2023

Conditions

Neoadjuvant Chemotherapy

Keywords

operable breast cancerskeletal mass indexneoadjuvant chemotherapypathologic responseL3 vertebra

Outcome Measures

Primary Outcomes (1)

  • Sarcopenic index

    skeletal muscle area (cm2)/height (m2) et L3 level

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Body mass index

    Through study completion, an average of 1 year.

Other Outcomes (1)

  • Residual cancer burden

    Through study completion, an average of 1 year.

Study Arms (2)

Pathologic complete response (pCR)

Patient with complete pathological response

Other: Neoadjuvant therapy

Pathologic incomplete response (non-pCR)

Patient with partial pathological response

Other: Neoadjuvant therapy

Interventions

Neoadjuvant therapyOTHER

To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Pathologic complete response (pCR)Pathologic incomplete response (non-pCR)

Eligibility Criteria

Age29 Years - 72 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

You may qualify if:

  • Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

You may not qualify if:

  • Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AcıbademAH

Istanbul, 34782, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Aysun Isiklar, M.D.

    Acıbadem Atunizade Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 30, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 20, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)