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Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size After Response to Neoadjuvant Chemotherapy

NCT05115279 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-11-10

No results posted yet for this study

Summary

Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers (1). The incidence of breast cancer increases with age (2, 3). Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage(4) Neoadjuvant chemotherapy (NACT) is considered the standard of care for the management of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease. (5). Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors(6) . Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates \[7\]. Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided (8).

Complete pathological response after neoadjuvant systemic treatment is high, while complete clinical response rates are even higher. Because it is difficult to localize the original tumor bed after a complete clinical and radiological response, marking the tumor before the start of neoadjuvant systemic treatment is required to enable breast-conserving surgery afterward. Achieving adequate margins of excision is an important component of breast surgery. Local recurrence rates are significantly higher for patients who have positive margins of excision (9) some prospective and retrospective data suggested that patients with BCT after neoadjuvant therapy may have an increased risk for the development of a local recurrence .

If this were true, there would be no further advantage of neoadjuvant therapy and this treatment option could be questioned altogether.

A common question raised with respect to performing breast-conserving therapy after neoadjuvant chemotherapy is the volume of breast tissue that should be resected

Conditions

  • Safety of Excision the New Tumor Size

Interventions

PROCEDURE

breast conservative surgery for post chemotherapy tumour size

* Skin preparation by povidine iodine. * Excision of the mass with safety margin. * Sentinel axillary lymph node or complete axillary clearance depend on axillary lymph node status * All specimens were oriented with sutures * A frozen section examination of the specimen was performed intraoperative * When the margin status was inadequate, a re-excision was performed * Closure as drawn by different oncoplastic technique

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-06-01
Completion
2024-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05115279 on ClinicalTrials.gov