the Effect of Therapeutic Mammoplasty on the Start of Adjuvant Chemotherapy

June 16, 2023 updated by: Mariam Nabil Anwer, Assiut University

Therapeutic Mammoplasty Doesn't Delay Adjuvant Therapy for Breast Cancer Patients

the purpose of this study was to examine the impact of therapeutic mammoplasty on the delivery of adjuvant chemotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One out of every eight women will be diagnosed with breast cancer in her lifetime, making it the most common cancer in women. Over the last decades the survival rate has increased slowly, which is currently estimated to be 85 % in developed countries. However, with an estimated annual number of breast cancer deaths of 537,000 worldwide, breast cancer still is the most important cause of death by cancer among women. Despite advances in different treatment modalities, about 45 % of all breast cancer patients still undergoes a mastectomy for adequate local control. The resulting loss of a breast may have a negative effect on body image, sexuality, and sense of femininity. (8) Oncoplastic breast techniques are being increasingly employed to allow breast conservation whilst maintaining a quality aesthetic outcome. Therapeutic mammoplasty (TM) describes multiple breast-conserving techniques1 which remove the breast tumour in combination with adjuvant radiotherapy (1). TM is available to women with early stage breast cancer with larger or ptotic breasts who would benefit from a reduction mammoplasty technique in addition to tumour removal. The use of TM is increasing worldwide, with the potential to deliver benefits both oncologically, in terms of increased tumour free margin width, and with an associated superior long-term aesthetic outcome. Despite increasing enthusiasm for the techniques there is limited data on long-term oncological safety or effects upon delivery of adjuvant treatments.TM techniques can enable a larger volume of tissue to be resected with the tumour6 enabling patients to have breast-conserving surgery for larger tumours. Just as the role of TM is expanding, adjuvant chemotherapy is increasingly being used in women with early stage breast cancer and if delivered in a timely fashion after the primary resection, decreases recurrence and improves overall survival (3). However, TM is associated with higher complication rates than traditional breast-conserving methods and one barrier to TM is the concern that post-operative complications may lead to a delay in initiation of chemotherapy or even omission. There is increasing evidence that immediate breast reconstruction has an effect on adjuvant chemotherapy delivery. Three recent series involving over 4000 patients suggest that immediate breast reconstruction does lead to a significant delay in the delivery of adjuvant chemotherapy (2). However, the clinical significance of this delay has not been established. On the contrary, a recent study performed by Doughty et al. compared 95 patients undergoing immediate breast reconstruction following mastectomy with cohorts having breast-conserving surgery and simple mastectomy with no reconstruction, in which no delay to commencement of adjuvant chemotherapy was noted. The majority of case series on TM do not comment on the timing of adjuvant treatments. When they are reported, studies vary between no delays to adjuvant treatment through to five studies reporting delays in between 1.9%9 and 6% of patients (8).

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

female patients between the age of 25 to 65 who underwent therapeutic ammoplasty and will recieve adjuvant chemotherapy

Description

Inclusion Criteria:

  • Oncoplastic procedures were proposed for patients in whom breast conservative treatment is possible on oncologic grounds but in whose cases a standard resection without reconstruction would result in poor cosmesis with the following criteria:

    1. Female patients with ages ranging from 25 to 65 years
    2. Patients with early surgically treatable breast cancer (Stage I, II and IIIa)
    3. Patients whose management was by surgery followed by adjuvant chemotherapy.
    4. Patients with tumors in any quadrant of the breast
    5. Patients with large/ptotic breasts (especially with brassiere size C, D or DD).
    6. patients underwent therapeutic mammoplasty as primary ttt for breast cancer.

Exclusion Criteria:

  • 1) Patients with a contraindication to breast conservative surgery. 2) Patients with small sized breasts, which are not suitable for reduction (with brassiere size A or B).

    3) Patients who are not compliant; Non-compliant patients included those demanding mastectomy for fear of local recurrence, patients not consenting to the proposed procedure after adequate counseling, those refusing post-operative adjuvant Radiotherapy, refusal of a reduction mammoplasty of the contralateral breast as a symmetrizing procedure and patients who are not able to consent such as mentally challenged patients.

    4) patients who have received neoadjuvant chemotherapy. 5) patients underwent conventional breast conservative surgery . 6) patient underwent immediate reconstruction surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assesing the complocation of therapeutic mammoplasty and whether it delays the start of adjuvant chemotherapy or not
Time Frame: about two months
noting the date of the operation and whether or not it delays the start of adjuvant chemotherapy due to any complications
about two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: abdelradi amdelsalam, proffessor, Assiut University
  • Study Director: mostapha thabet, professor, Assiut University
  • Study Director: negmeldeen abulnaga, assistant lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • tmp and adjuvant chemotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

about two years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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