RESPONDER Trial - Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy after Neoadjuvant Chemotherapy in Breast Cancer

Not Applicable

• Conditions: C50.0; C50.8; Nipple and areola; Overlapping lesion of breast

• Registration Number: DRKS00011761
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Study Completion: 2019-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Female
• Target Recruitment: 452

Inclusion Criteria

Female patients with primary breast cancer after Neoadjuvant Chemotherapy (NACT) treatment
which has been performed for at least 12 weeks and resulted in cPR or cCR (see below);

>/=18 years;

any cT and cN stage, except cT4 stages;

any routine breast cancer surgical intervention planned according to guidelines (breast
conservation or mastectomy);

residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography;

diagnosis of imaging complete or partial response according to RECIST 1.1 by at least
mammography or ultrasound, according to local routine);

inclusion of only one breast per patient, in bilateral cancer one breast can be included;

in case of multicentric disease: confirmation of the same tumorbiological subtype defined by
immunohistology in at least 2 lesions;

ability of subject to understand character and individual consequences of the clinical trial;

written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

palliative or recurrent breast cancer;

in case of clip marker = target lesion: dislocation of marker (>5mm distance to the initial lesion
border at the time of clip placement);

contraindication for VAB or associated procedures (e.g. local anesthesia);

pregnancy and lactation;

held in an institution by legal or official order;

legally incapacitated

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the false negative rate (=FNR). The false negative rate (FNR) will be calculated as the quotient of the number of cases with pCR in VAB” and residual tumor in surgical specimen (false negative VAB results), divided by the total number of cases with residual tumor in surgical specimen in the cohort of the confirmatory primary outcome analysis. The primary endpoint will be assessed the pathologic report (comparison of pathologic result of the biopsy with the pathological result of surgical specimen).

Secondary Outcome Measures

Name	Time	Method
egative predictive value (NPV), positive predictive value (PPV), sensitivity, specificity. The secondary endpoints will be analysed descriptively for the whole cohort and different subgroups: (1) Tumor biology, (2) clinical response, (3) assessment of representiveness, (4) trial sites, (5) guidance method (mammography / ultrasound).