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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel Drug: Carboplatinum Drug: Epirubicin Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- -The rate of pCR in the breast and axilla (ypT0/is, ypN0) [ Time Frame: 20 weeks ]
- 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.
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
|Principal Investigator:||Christel Fontaine, Dr.||Universitair Ziekenhuis Brussel|