Biopsy
ProcedureBiopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
NCT Number: NCT03077776
A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Jean Perrin, Clermont-Ferrand, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
Biopsy of metastatic site to be performed at the time of relapse
Time frame: pCR will be defined at the time of surgery on the tumor specimen
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system)
Time frame: from surgery until 5 years post-surgery
the time from neoadjuvant treatment initiation until the date of the first occurrence of one of the following events: invasive ipsilateral breast tumour recurrence (same breast), local /regional invasive recurrence, invasive contra lateral breast cancer, appearance of metastasis, second primary invasive cancer (non-breast cancer), ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, death attributable to any cause.
Time frame: from surgery until 5 years post-surgery
the time from neoadjuvant treatment until death due to any cause
UNICANCER
Other
Acronym: TRACERX-TNBC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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