Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB) (NeoVAB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03876951|
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 12, 2019
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.
If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.
|Condition or disease||Intervention/treatment||Phase|
|Vacuum-assisted Biopsy||Diagnostic Test: Vacuum-assisted biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: vacuum-assisted biopsy
Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery
Diagnostic Test: Vacuum-assisted biopsy
Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.
- False negative rate of vacuum-assisted biopsy [ Time Frame: During the surgery ]Absence of invasive and in-situ carcinoma on vacuum-assisted biopsy but presence of invasive or in-situ carcinoma on the surgical specimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876951
|Contact: Charles COUTANT||22.214.171.124.75.00||CCoutant@cgfl.fr|
|Contact: Emilie REDERSTORFF||03 45 34 81 firstname.lastname@example.org|
|Centre Georges François Leclerc||Not yet recruiting|
|Dijon, France, 21000|
|Contact: Emilie REDERSTORFF 03 45 34 81 16 email@example.com|
|Principal Investigator: Charles COUTANT|