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Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT04224922
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Information provided by (Responsible Party):
Dr Fontaine Christel, AZ-VUB

Tracking Information
First Submitted Date  ICMJE January 7, 2020
First Posted Date  ICMJE January 13, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
-The rate of pCR in the breast and axilla (ypT0/is, ypN0) [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • Evaluation of tumor infiltrating lymphocytes on the residual tumor [ Time Frame: 20 weeks ]
    Histopathological analysis of the lymphocyte infiltrate is performed on hematoxylin and eosin- stained sections of the core biopsies and afterwords on the resection specimen after neoadjuvant chemotherapy. Ancillary techniques and immunohistochemistry have no additional value upon this date, and are not recommanded. The overall assessment has to be made for the whole tumor area, regardless of hot spots. All mononuclear cells including lymphocytes and plasma cells should be scored (granulocytes and other polymorphonuclear leukocytes are excluded). The quantitative assessment of other mononuclear cells such as dendritic cells and macrophages is currently not recommended. TILs should be reported for the intratumoral lymphocytes (as first proposed by Denkert in 2010). Stromal lymphocytes (Str-Ly) are defined as the percentage of tumor stroma area that contains a lymphocytic infiltrate without direct contact to tumor cells.
  • Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 [ Time Frame: 20 weeks ]
  • Evaluation of the drug delivery [ Time Frame: 20 weeks ]
    Patient compliance for paclitaxel and carboplatin and for epirubicin and cyclophosphamide will be assessed by the investigator and/or study personnel at each patient visit. To accurately determine the patient's drug exposure throughout the study, the following information must be reported on the Drug Administration Record CRF pages and in the source document. Planned dose administration, Actual total daily dose administrated, Regimen, Start and end date of drug administration, Dose change, Reason for dose change
  • Evaluation of clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla. [ Time Frame: 20 weeks ]
  • Evaluation of breast-conserving surgery rate [ Time Frame: 20 weeks ]
  • Evaluation of progression free survival [ Time Frame: 20 weeks ]
  • Evaluation of overall survival [ Time Frame: 20 weeks ]
  • Evaluation of percentage of patients with BRCA1 or BRCA2 in this population. [ Time Frame: 20 weeks ]
  • genome analysis on tissue samples [ Time Frame: 20 weeks ]
    Tumor tissue samples (FFPE) for genetic research will be obtained from consenting patients both at screening and at surgery. Genome analysis will be performed on (1) DNA extracted from EDTA blood (10ml) collected at the start of the treatment and (2) on DNA extracted from FFPE tumor tissue collected before the start of the neoadjuvant chemotherapy and after surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
Official Title  ICMJE A Prospective, Belgian Multi-center, Single-arm, Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
Brief Summary This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Paclitaxel
  • Drug: Carboplatinum
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
Study Arms  ICMJE Experimental: single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
Interventions:
  • Drug: Paclitaxel
  • Drug: Carboplatinum
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2020)
63
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage II-III operable triple negative (ER and PR < 10%; Her2 IHC 0-1 or FISH <2.0) breast cancer in women age > 18. For patients aged 65 or older the G8 geriatric screening test should be > 14 (on a total of 17).
  • Baseline mammography, US. MR of the breast on clinical indication.
  • FNA of suspicious axillary lymph node is indicated
  • Pre-treatment SN biopsy is indicated in clinical N0
  • Measurable loco-regional disease
  • Adequate bone marrow function, defined as

    • Absolute neutrophil count(ANC) >1500*109/L
    • Platelet count >100.000*109/L
  • Adequate liver function defined as

    • Serum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome
    • AST and/or ALT <2.5*ULN
    • Alkaline phosphatase <2.5*ULN
  • Normal cardiac function measured by ultrasound with a left ventricular function > 55%
  • Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function)

Exclusion Criteria:

  • T4d breast tumor
  • Bilateral breast cancer
  • Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.
  • Pregnant or lactating patients
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04224922
Other Study ID Numbers  ICMJE BSMO-2014-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Fontaine Christel, AZ-VUB
Study Sponsor  ICMJE AZ-VUB
Collaborators  ICMJE
  • Universitaire Ziekenhuizen Leuven
  • Universitair Ziekenhuis Brussel
Investigators  ICMJE
Principal Investigator: Christel Fontaine, Dr. Universitair Ziekenhuis Brussel
PRS Account AZ-VUB
Verification Date January 2020

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