Breast reconstruction and neoadjuvant radiotherapy, a changing algorithm.

Breast reconstruction and neoadjuvant radiotherapy, a changing algorithm. - Breast Reconstruction and Neoadjuvant Radioterapy (BRENAR)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51819

Enrollment

Registered

2022-12-20

Start date

2023-10-03

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer malignant neoplasm of the breast

Interventions

The intervention consists of NART followed by mastectomy with immediate reconstruction, where the standard treatment is mastectomy and PMRT, with an immediate or delayed reconstruction.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Women >= 18 years with: - breast cancer - an indication for mastectomy - an indication for radiotherapy - wish for a breast reconstruction

Exclusion criteria

Exclusion criteria: - Legal incapacity - Not able to understand and sign Dutch written informed consent - Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla - Pregnant or lactating. - Smoking - BMI > 35 kg/m2 - cT4 tumour (and skin sparing mastectomy not possible)

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Acute post-surgical complications at 3 months following mastectomy and immediate breast reconstruction after NART in the treatment of breast cancer.	—

Secondary

Measure	Time frame
1. Other adverse events following NART or surgery other than described in the primary outcome measure. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Time Frame: Within 3 months after both breast reconstruction and radiotherapy. 2. Patient-reported Satisfaction with Breasts, Physical, emotional and sexual well-being (as measured using BREAST-Q). Time Frame: At baseline and 3 months after definitive treatment (definitive breast reconstruction). The BREAST-Q is a multiscale, multimodule, patient-reported outcome instrument measuring important aspects of health-related quality of life and patient satisfaction in women who undergo breast surgery.The BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program. Each domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life). 3. Physician-reported cosmetic results (as assesses by a panel of experts on breast photos obtained as part of standard of care). Time Frame: at basline and 3 months after definitive breast reconstruction surgery. The clinical investigators will assess the physician-reported aesthetic outcome from photographs using the Aesthetic Items Scale,12 which is a standardised method. Five standardised photographs (frontal, oblique, and lateral) will be taken before and at 3 months after placement of the breast implant. The photos will be evaluated independently by five plastic surgeons. All photographs will be compiled into a slideshow presentation. They will be shown in a random order without any additional information (eg, on preoperative or postoperative status, reconstruction method used, complications). To minimise bias, blank slides will be shown between photographs and the random order of the photographs was different for each observer. The surgeons will rate the aesthetic outcome on five items w	—

Measure

Time frame

1. Other adverse events following NART or surgery other than described in the primary outcome measure. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Time Frame: Within 3 months after both breast reconstruction and radiotherapy. 2. Patient-reported Satisfaction with Breasts, Physical, emotional and sexual well-being (as measured using BREAST-Q). Time Frame: At baseline and 3 months after definitive treatment (definitive breast reconstruction). The BREAST-Q is a multiscale, multimodule, patient-reported outcome instrument measuring important aspects of health-related quality of life and patient satisfaction in women who undergo breast surgery.The BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program. Each domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life). 3. Physician-reported cosmetic results (as assesses by a panel of experts on breast photos obtained as part of standard of care). Time Frame: at basline and 3 months after definitive breast reconstruction surgery. The clinical investigators will assess the physician-reported aesthetic outcome from photographs using the Aesthetic Items Scale,12 which is a standardised method. Five standardised photographs (frontal, oblique, and lateral) will be taken before and at 3 months after placement of the breast implant. The photos will be evaluated independently by five plastic surgeons. All photographs will be compiled into a slideshow presentation. They will be shown in a random order without any additional information (eg, on preoperative or postoperative status, reconstruction method used, complications). To minimise bias, blank slides will be shown between photographs and the random order of the photographs was different for each observer. The surgeons will rate the aesthetic outcome on five items w

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)