Muscle Parameters and Pathological Response in Breast Cancer Patients

• Sponsor: Acıbadem Atunizade Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06151379
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neoadjuvant Chemotherapy	Other: Neoadjuvant therapy

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

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response
• Actual Study Start Date: Mar 1, 2023
• Actual Primary Completion Date: Sep 30, 2023
• Actual Study Completion Date: Oct 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Pathologic complete response (pCR) Patient with complete pathological response	Other: Neoadjuvant therapy; To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Pathologic incomplete response (non-pCR) Patient with partial pathological response	Other: Neoadjuvant therapy; To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Outcome Measures

Primary Outcome Measures

1. Sarcopenic index [Through study completion, an average of 1 year.]

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

Secondary Outcome Measures

1. Body mass index [Through study completion, an average of 1 year.]

   weight (kg)/height (m2)

Other Outcome Measures

1. Residual cancer burden [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 29 Years to 72 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AcıbademAH	Istanbul		Turkey	34782

Sponsors and Collaborators

• Acıbadem Atunizade Hospital

Investigators

• Principal Investigator: Aysun Isiklar, M.D., Acıbadem Atunizade Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ebru Yilmaz, Principal Investigator, Acıbadem Atunizade Hospital
• ClinicalTrials.gov Identifier: NCT06151379
• Other Study ID Numbers: AcıbademAH
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ebru Yilmaz, Principal Investigator, Acıbadem Atunizade Hospital: operable breast cancer; skeletal mass index; neoadjuvant chemotherapy; pathologic response; L3 vertebra

Study Results

No Results Posted as of Nov 30, 2023