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Spots Global Cancer Trial Database for the Effect of Therapeutic Mammoplasty on the Start of Adjuvant Chemotherapy

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Trial Identification

Brief Title: the Effect of Therapeutic Mammoplasty on the Start of Adjuvant Chemotherapy

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

Study ID: NCT05920070

Study Description

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

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).

Keywords

Eligibility

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Name: abdelradi amdelsalam, proffessor

Affiliation: Assiut University

Role: STUDY_DIRECTOR

Name: mostapha thabet, professor

Affiliation: Assiut University

Role: STUDY_DIRECTOR

Name: negmeldeen abulnaga, assistant lecturer

Affiliation: Assiut University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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