Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920070
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-06-16
Brief Title:
the Effect of Therapeutic Mammoplasty on the Start of Adjuvant Chemotherapy
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Therapeutic Mammoplasty Doesnt Delay Adjuvant Therapy for Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 537000 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 treatmentsTM 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 199 and 6 of patients 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None