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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

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date April 12, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
False negative rate of vacuum-assisted biopsy [ Time Frame: At 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.
Change History Complete list of historical versions of study NCT03876951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Vacuum-assisted Biopsy
Intervention  ICMJE Diagnostic Test: Vacuum-assisted biopsy
Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.
Study Arms  ICMJE Experimental: vacuum-assisted biopsy
Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery
Intervention: Diagnostic Test: Vacuum-assisted biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
67
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
66
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles COUTANT 33.3.80.73.75.00 CCoutant@cgfl.fr
Contact: Emilie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876951
Other Study ID Numbers  ICMJE NeoVAB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor  ICMJE Centre Georges Francois Leclerc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Georges Francois Leclerc
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP