Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03737266
• Collaborator: (none)
• Enrollment: 340
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Surgery	Procedure: Sonographically assisted breast surgery; Procedure: Conventional breast surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sonographically assisted breast surgery Sonography assisted breast surgery	Procedure: Sonographically assisted breast surgery; Sonography; Procedure: Conventional breast surgery; Conventional
Active Comparator: Conventional breast surgery Conventional breast surgery	Procedure: Sonographically assisted breast surgery; Sonography; Procedure: Conventional breast surgery; Conventional

Outcome Measures

Primary Outcome Measures

1. R0 resection rate [3 years]

Secondary Outcome Measures

1. Weight of primary resedate [3 years]

2. Time for cut and sew [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 to 80 years

• Female

• Presurgical validated breast cancer

• Unifocal to multifocal findings

• Palpable and/o non-palpable findings

• Neoadjuvant chemotherapy

• Indication for breast conserving therapy

• General operation ability and anesthesia ability

• Consent to conventional breast conserving breast surgery with wire marking

• Ability and will to follow the study conditions

• Written declaration of consent after clarification

Exclusion Criteria:

• Sonographically not clearly delineate resection areal

• Exclusion criteria for breast conserving therapy

• Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department for Women's Health	Tübingen	BW	Germany	72086

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03737266
• Other Study ID Numbers: Seno_Ex_MAC 003
• First Posted: Nov 9, 2018
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 23, 2021