A prospective, Belgian multi-center, single-arm, phase II study consists in a pre-surgery weekly paclitaxel and carboplatin chemotherapy treatment followed by epirubicin and cyclophosphamide chemotherapy treatment on the 2 weeks at patients with stage II and III sormono-sensitive breast cancer.
- Conditions
- Stage II and III triple negative breast cancer patients suitable for preoperative chemotherapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003723-21-BE
- Lead Sponsor
- Belgian Society of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 63
-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
oAbsolute neutrophil count(ANC) >1500*109/L
oPlatelet count >100.000*109/L
-Adequate liver function defined as
oSerum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert’s Syndrome
oAST and/or ALT <2.5*ULN
oAlkaline 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To determine the rate of pCR in the breast and axilla (ypT0/is, ypN0). Pathological complete response is defined as no presence of invasive residuals in the breast and resected axillary lymph nodes. ;Secondary Objective: - To evaluate the toxicity of the study regimen<br>- To evaluate the drug delivery<br>- To evaluate clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla.<br>- To evaluate breast-conserving surgery rate<br>- To evaluate progression free survival <br>- To evaluate overall survival<br>- To evaluate the percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population.<br>- To evaluate tumor infiltrating lymphocytes on the residual tumor<br>- To do genome analysis on tissue samples;Primary end point(s): - The rate of pCR in the breast and axilla (ypT0/is, ypN0);Timepoint(s) of evaluation of this end point: After surgery when part 1 and 2 of treatment are ended
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Safety<br>- The drug delivery<br>- Clinical response rate<br>- Rate of breast conserving surgery<br>- PFS<br>- OS<br>- Percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population<br>- Percentage of tumor infiltrating lymphocytes on residual tumor<br>- Subsequent genomic studies on the tumor and germline DNA's;Timepoint(s) of evaluation of this end point: during and after part 1 and 2 of treatment