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Completed

NCT Number: NCT06151379

Muscle Parameters and Pathological Response in Breast Cancer Patients

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

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Key information

Conditions

Neoadjuvant Chemotherapy

Age range

29 year–72 year

Sex eligibility

Female

Study type

Observational

Primary location

AcıbademAH

Istanbul, 34782, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Neoadjuvant Therapy

Other

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

Primary outcomes

  1. Sarcopenic index

    Time frame: Through study completion, an average of 1 year.

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

Secondary outcomes

  1. Body mass index

    Time frame: Through study completion, an average of 1 year.

    weight (kg)/height (m2)

Other outcomes

  1. Residual cancer burden

    Time frame: Through study completion, an average of 1 year.

    Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy.

Sponsors and collaborators

Lead sponsor

Acıbadem Atunizade Hospital

Other

Registry information

Official study title

The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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