## Protocol Section
### Identification Module
**NCT ID:** NCT06151379

**Brief Title:** Muscle Parameters and Pathological Response in Breast Cancer Patients

**Official Title:** The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response

#### Organization Study ID Info
**ID:** AcıbademAH
#### Organization
**Class:** OTHER
**Full Name:** Acıbadem Atunizade Hospital
### Status Module
#### Completion Date
**Date:** 2023-10-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-30

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-11-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-04
**Study First Submit QC Date:** 2023-11-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Acıbadem Atunizade Hospital

#### Responsible Party

**Investigator Affiliation:** Acıbadem Atunizade Hospital

**Investigator Full Name:** Ebru Yilmaz

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Neoadjuvant Chemotherapy

**Keywords:**

- operable breast cancer

- skeletal mass index

- neoadjuvant chemotherapy

- pathologic response

- L3 vertebra

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 69

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient with complete pathological response

**Intervention Names:**

- Other: Neoadjuvant therapy

**Label:** Pathologic complete response (pCR)

#### Arm Group 2

**Description:** Patient with partial pathological response

**Intervention Names:**

- Other: Neoadjuvant therapy

**Label:** Pathologic incomplete response (non-pCR)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pathologic complete response (pCR)

- Pathologic incomplete response (non-pCR)

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

**Name:** Neoadjuvant therapy

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Residual cancer burden

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

#### Primary Outcomes

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

**Measure:** Sarcopenic index

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

#### Secondary Outcomes

**Description:** weight (kg)/height (m2)

**Measure:** Body mass index

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

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 72 Years

**Minimum Age:** 29 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** AcıbademAH

**Zip:** 34782

#### Overall Officials

**Official 1:**

**Affiliation:** Acıbadem Atunizade Hospital

**Name:** Aysun Isiklar, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
