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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)

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ClinicalTrials.gov Identifier: NCT03876951
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

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

Detailed Description:
A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient aged 18 years or older.
  2. Written informed consent provided.
  3. Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
  4. Patients eligible for breast conservation after NAC.
  5. Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER2.
  6. Clinical complete response after NAC.
  7. Radiological (mammography, breast US, breast MRI) complete response after NAC.
  8. Patients predicted to be node-negative at treatment initiation.

Exclusion Criteria:

  1. Patient younger than 18 years old.
  2. Pregnant or breastfeeding women.
  3. Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
  4. Bilateral breast cancer.
  5. Contraindication to MRI.
  6. Contraindication to breast conservation
  7. Patients with a BRCA mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer.
  8. Patients with limitation of freedom or under guardianship
  9. Inability for psychological reasons
  10. Hypersensitivity to local anaesthesia
  11. Initial imaging showing ACR6 micro calcifications and/or ACR6 non-mass enhancement associated to the index lesion

Information from the National Library of Medicine

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


Contacts
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Contact: Charles COUTANT 33.3.80.73.75.00 CCoutant@cgfl.fr
Contact: Emilie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr

Locations
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France
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21000
Contact: Emilie REDERSTORFF    03 45 34 81 16    erederstorff@cgfl.fr   
Principal Investigator: Charles COUTANT         
Sponsors and Collaborators
Centre Georges Francois Leclerc

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03876951     History of Changes
Other Study ID Numbers: NeoVAB
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Georges Francois Leclerc:
breast cancer
neoadjuvant chemotherapy
vacuum-assisted biopsy
pathological complete response