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JOURNAL ONKOLOGIE – STUDIE

Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients With rCR and pCR in the Breast After NAST

Rekrutierend

NCT-Nummer:
NCT04101851

Studienbeginn:
Januar 2021

Letztes Update:
06.04.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Toralf Reimer, MD PhD

Collaborator:
European Breast Cancer Reseach Association of Surgical Trialists, University Medicine Rostock, Rostock, Germany (sponsor), Else Kröner-Fresenius-Stiftung (funding), German Society of Senology (funding),

Studienleiter

Oreste D Gentilini, MD
Study Chair
Breast Unit, San Raffaele University and Research Hospital, Milan, Italy
Toralf Reimer, Prof.
Study Chair
Department of Obstetrics and Gynecology, University of Rostock, Germany

Kontakt

Studienlocations
(3 von 17)

Alle anzeigen

Studien-Informationen

Detailed Description:

EUBREAST-01 is a prospective non-randomized, single-arm surgical trial. Included patients

will be recruited for the experimental arm (no axillary SLNB in cases with breast pCR after

NAST) exclusively. EUBREAST-01 is an international multicentric trial and designed by

European Breast Cancer Research Association of Surgical Trialists (EUBREAST). The University

Medicine Rostock (Germany) will overtake the sponsorship for the trial.

Duration of recruitment is 2 years among 30 German, 10-15 Italian, 3 Spanish, 3 Swedish, and

3 Austrian study centres. The total number of patients to be recruited into the trial will be

267. All participating centres are experienced in conduction of clinical trials and stated at

least a rate of 50 primary breast cancer diagnosis per year. At least 30% of all primary

breast cancer are TNBC or HER2-positive tumors. The great majority of these cases will be

diagnosed in tumor stage T1c-T3 (>1cm). The NAST with chemotherapy (plus anti-HER2 therapy if

HER2-positive) is standard for this cohort in Germany, Austria, Italy, Spain and Sweden. If

each study center will recruit 3 cases per year, the planned recruitment of 267 patients

(per-protocol analysis) will be reached in 2 years.

Efficacy analyses will be conducted after a follow-up of 3 years for each patient regarding

the primary outcome and after 5 years follow-up for the secondary outcomes. No interim

analysis is planned. Patients will be assessed for disease recurrence according to standard

national clinical practice over a period of at least 5 years. Longest follow-up is 7 years.

History and physical examination will be performed every 6 months for the first 36 months and

yearly thereafter. Annual mammography and sonography will be required; other testing will be

based on symptoms and investigator preference.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent prior to breast-conserving surgery, including expected

cooperation of the patients for follow-up, must be obtained and documented according

to the European regulatory requirements

- Histologically confirmed unilateral primary invasive carcinoma of the breast (core

biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery is

planned.

- Age at diagnosis at least 18 years

- imaging techniques with estimated tumor stage between cT1c-T3 prior to NAST

- triple-negative or HER2-positive invasive breast cancer

- clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0)

- in cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA)

biopsy of the sonographically suspected lymph node is required

- no evidence for distant metastasis (M0)

- standard NAST with radiologic complete response (rCR)

- planned breast-conserving surgery with postoperative external whole-breast irradiation

(conventional fractionation or hypofractionation)

Exclusion Criteria:

- History of malignancy within last 5 years, except curatively treated basalioma of the

skin and carcinoma in situ of the cervix

- Time since last cycle of NAST >3 months (optimal <1 month)

- histologically non-invasive breast carcinoma

- ER-positive/HER2-negative disease (triple-positive tumors are allowed)

- cT4 or iT4 tumors

- pregnant or lactating patients

- no radiologic complete response at the end of NAST

- planned total mastectomy after NAST

- planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast

irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost

techniques

- male patients

Studien-Rationale

Primary outcome:

1. rate of axillary recurrence-free survival (ARFS) after breast-conserving surgery (Time Frame - 3-year)



Secondary outcome:

1. invasive disease-free survival (Time Frame - 5-year)

2. overall survival (Time Frame - 5-year)

3. locoregional disease-free survival (Time Frame - 5-year):
no tumor in the ipsilateral breast or ipsilateral supraclavicular, infraclavicular, internal mammary or axillary nodes

4. distant disease-free survival (Time Frame - 5-year)

5. ipsilateral axillary recurrence rate (Time Frame - 5-year):
each patient with 5-year follow-up

6. Diagnostic accuracy of imaging methods for pathologic complete response (breast pCR) after NAST (Time Frame - 1-year)

Geprüfte Regime

  • omission of SLNB:
    After radiologic complete remission at the end of NAST all patients will be treated with breast-conserving surgery alone without any axillary surgery.

Quelle: ClinicalTrials.gov


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