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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Paclitaxel Drug: Carboplatinum Drug: Epirubicin Drug: Cyclophosphamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
Drug: Paclitaxel
Drug: Carboplatinum
Drug: Epirubicin
Drug: Cyclophosphamide



Primary Outcome Measures :
  1. -The rate of pCR in the breast and axilla (ypT0/is, ypN0) [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 [ Time Frame: 20 weeks ]
  3. 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


  4. Evaluation of clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla. [ Time Frame: 20 weeks ]
  5. Evaluation of breast-conserving surgery rate [ Time Frame: 20 weeks ]
  6. Evaluation of progression free survival [ Time Frame: 20 weeks ]
  7. Evaluation of overall survival [ Time Frame: 20 weeks ]
  8. Evaluation of percentage of patients with BRCA1 or BRCA2 in this population. [ Time Frame: 20 weeks ]
  9. 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.




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:

  • 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

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): NCT04224922


Locations
Show Show 18 study locations
Sponsors and Collaborators
AZ-VUB
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Christel Fontaine, Dr. Universitair Ziekenhuis Brussel
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Responsible Party: Dr Fontaine Christel, Principle Investigator, AZ-VUB
ClinicalTrials.gov Identifier: NCT04224922    
Other Study ID Numbers: BSMO-2014-01
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cyclophosphamide
Epirubicin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors