Breast Cancer Clinical Trial
— BRENAROfficial title:
Breast Reconstruction and Neoadjuvant Therapy, a Changing Algorithm
NCT number | NCT05216900 |
Other study ID # | 80252 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | December 4, 2026 |
The purpose the BRENAR pilot study is to assess acute post-surgical complications following mastectomy and immediate breast reconstruction after neoadjuvant radiotherapy (NART). The investigators hypothesize that NART will avoid the negative effects of postmastectomy radiotherapy (PMRT) on the capsule of an implant, or on the skin and underlying tissue of an autologous flap, and would therefore lead to better cosmetic results, better quality of life and less complications compared to PMRT. If this hypothesis is confirmed, NART would allow more patients to undergo an immediate reconstruction resulting in superior cosmetic results and quality of life. Furthermore, the use of RT in a neoadjuvant setting could potentially result in a shorter overall loco-regional treatment time from diagnosis to receiving the last locoregional treatment. However, this pilot study will mainly assess whether or not the post-surgical complications of breast reconstruction with NART are acceptable. Further study to investigate long term quality of life and oncologic follow-up results will be conducted after this pilot study, if complication rates are acceptable.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 4, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Females at least 18 years of age. - WHO performance scale =2 - Adequate communication and understanding skills of the Dutch language - Able to understand and sign Dutch written informed consent - Indication for mastectomy and a known indication for (adjuvant) radiotherapy of at least the chestwall. To obtain information on the indication for RT, before the mastectomy is performed, it may be necessary to perform a separate SNP and/or targeted axillary dissection prior to inclusion, i.e. - Stage III (cT3N1, cT0-2N2-3) or cN1 with more than 3 suspicious nodes at initial diagnosis - A positive SN/TAD* pre- breast surgery in case of: - cT1-2N0 and less than 3 RF** at initial diagnosis and cCR on imaging*** - cT3N0 and no risk factor at initial diagnosis - If the indication for radiotherapy is not yet clear, and is only indicated when there is a pathological lymph node present, a sentinel node procedure or targeted axillary dissection (TAD) will be performed first to check for the lymph node status. A sentinel node procedure (SNP) will be performed under general anesthesia in order to explore regional lymph nodes. For cT1-3N0 patients, it is known that about 25% has a positive axillary node after neoadjuvant chemotherapy (50);for patients with cT1-3N+ breast cancer, about 55-70% still have positive nodes after neoadjuvant chemotherapy, which is dependent of receptor status 29,30,31,32,33. Consequently, we may have to ask for informed consent 2-4 times more patients than we would need for this pilot study. - risk factors are: angio invasion, Grade III, Age = 40 yrs, triple negative *** In patients with cT1-2N0 with at least 3 RF a tumour biopsy can be considered prior to surgery in case of neoadjuvant chemotherapy, since in case of no pCR the indication for RT is already set, and an SN or TAD prior to breast surgery is not required. Exclusion Criteria: - study: - 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 - Collagen synthesis disease - MRI absolute contraindications as defined by the Radiology Department - Age < 18 year - Pregnant or lactating. - Smoking - BMI > 35 kg/m2 - cT4 tumour (and skin sparing mastectomy not possible) - If NAC in cT1-2N0 and 3 RF: in triple negative or Her2 positive (with concern for under treatment of adjuvant therapy) and no tumor cells in preoperative biopsy* - NB: If neoadjuvant chemotherapy is given, and if the indication for adjuvant systemic treatment is dependent on the presence or absence of a pathological complete response pCR (such as in patients with a triple negative or Her2 positive tumour), centres can choose A) to exclude these patients, or B) only to include these patients when a non-pCR is proven via a biopsy prior to the start of the RT. Earlier studies in partial breast RT showed that pCR rate of NART only, followed by surgery < 6-8 weeks is very low in the general breast cancer population (17 of the 110), whilst it seems to be higher in patients with triple negative (6/8) and Her2 positive (1/1) (personal communication Sophie Bosma, trial on Preoperative Accelerated Partial Breast Irradiation, PAPBI trial 34. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maarse Wiesje | Bilthoven | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Alexander Monro Hospital, Bilthoven, Amsterdam UMC, Cancer Center Amsterdam grant for innovative research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute post-surgical complication rate at 3 months following mastectomy and immediate breast reconstruction after NART in the treatment of breast cancer. | Surgical complications are defined as any complication requiring surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage) within a period up to three months after the final reconstruction, defined and scored using the Clavien-Dindo Classification of Surgical Complications (C-DC)37: - Infection - Hematoma - Loss of implant/expander/flap - (Fat)Necrosis | 3 months following mastectomy and immediate breast reconstruction (latest intervention, being either autologous recosntruction or silicone implant) | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Other adverse events following NART or surgery other than described in the primary outcome measure. | Within 3 months after both breast reconstruction and radiotherapy | |
Secondary | Patient-reported Satisfaction with Breasts, Physical, emotional and sexual well-being (as measured using BREAST-Q) | 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). | At baseline and 3 months after definitive treatment (definitive breast reconstruction). | |
Secondary | The Aesthetic Items Scale; Physician-reported cosmetic results of the reconstructed breast | 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 will be taken before and at 3 months after placement of the breast implant. The photos will be evaluated independently by five plastic surgeons. The surgeons will rate the aesthetic outcome on five items with a five-point Likert scale12. The breasts are evaluated with respect to volume, shape, symmetry, scars, and nipple areola complex. For each of these items a 5-point Likert scale is used for scoring. This scale ranges from "very dissatisfied," "dissatisfied," "neutral," "satisfied," to "very satisfied." The summed score of the 5 items as the Total Aesthetic Score (TAS) with high scores meaning better outcome. * Dikmans et al. The Aesthetic Items Scale: A Tool for the Evaluation of Aesthetic Outcome after Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Mar 1;5(3) |
3 months after definitive breast reconstruction surgery | |
Secondary | Timely initiation of (possible) adjuvant therapy | In three months after mastectomy | ||
Secondary | Pathological complete response (pCR) assessed in mastectomy specimen | A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0). Response of the breast was assessed according to EUSOMA. Complete pathological response, either (i) no residual carcinoma or (ii) no residual invasive carcinoma but DCIS present. Partial response to therapy, either (i) minimal residual disease/near total effect (e.g. only a few loose tumour cells or tumour cells located in small groups) or (ii) evidence of response to therapy but with 10-50% of tumour remaining or (iii) >50% of tumour cellularity remains evident, when compared to the previous core biopsy sample, although some features of response to therapy are present (e.g. fibrosis). No response: no evidence of response to therapy. |
Within 2 weeks after mastectomy |
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