BSMO-2014-01

BSMO

C. Heymanslaan 10, Ghent, Belgium, 9000

Dr. Fontaine, UZ Brussel, +32 2477.64.15, christel.fontaine@uzbrussel.be

Dr. Fontaine, UZ Brussel, +32 2477.64.15, christel.fontaine@uzbrussel.be

No

No

No

Final

30 Sep 2020

No

Yes

30 Sep 2020

No

- 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.

Signed Informed consent, in this consent is explained that the patient data is anonymized. Safety data will be collected on a continuous basis and will be reviewed by the Sponsor in order to ensure that it is appropriate to continue the study

09 Mar 2015

No

No

Belgium: 63

63

63

0

0

0

0

0

0

53

10

0

Treatment phase (overall period)

Non-randomised - controlled

Carboplatinum

Solution for injection

Intravenous use

In the first part of the adjuvant chemotherapy all patients should receive weekly paclitaxel at a dose of 80mg/m² in a 1-h infusion followed by carboplatin at an area under the curve(AUC of 2mg*min/ml) in 30-min infusion given weekly for 12 weeks

AUC

Solution for injection

Intravenous use

(AUC of 2mg*min/ml) in 30-min infusion given weekly for 12 weeks

Epirubicine

Solution for injection

Intravenous use

2 weekly epirubicin at a dose of 90mg/m² in 1-h infusion

cyclophosphamide

Solution for injection

Intravenous use

cyclophosphamide at a dose of 600mg/m² in a 30 to 60 min infusion

Treatment phase

Treatment Phase

Single arm study

Single arm study

Single arm study

Single arm study, fantom arm to resolve the query

After breast surgery pathologic complete response will be assessed by the pathologist as no invasive residual tumor in the breast and axilla (ypT0/is, ypN0 (f+or f-). ypN0f+ means that no metastatic disease is detected in the lymph node but there is evidence of response or downstaging due to fibrosis in the lymph node; ypN0f- means that there is no metastatic disease nor evidence of response or downstaging detected in the lymph node. In case of metastatic disease in the lymph node we refer to the TNM classification. In case there was no clinical lymph node involvement baseline, and the sentinel procedure was negative, no further axillary lymph node dissection is required after neoadjuvant chemotherapy, and only the ypT stage will be assessed pathologically. The yPN status will be considered as yPN0 in that case. Partial response to therapy will be considered as minimal residual disease if< 10% of the invasive residual tumor is remaining after surgery or considered as evidence of r

Primary

To determine the pCR rate 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. After 3 months therapy

The study size sample has been calculated according to the optimal Simon’s two-stage design method. The target sample size is 63patients with a 80% power to detect a pCR rate of > or=47% (alfa=0.05).The optimal Simon two-stage design is used to test the null hypothesis (H0) that the weekly regimen of paclitaxel and carboplatin followed by dose dense cyclophosphamide and epirubicin elicite a pCR(ypT0/is, ypN0) rate in a cohort of triple negative patients of < or =30% versus the alternative hypoth

Treatment Phase v Single arm study v Single arm study

189

Pre-specified

0.05

1-sided

Standard deviation

0.05

Adverse events that begin or worsen after start of treatment should be recorded in the CRF. Conditions that were already present at the time of informed consent should be recorded in the CRF. Throughout the duration of the study according NCICTC AE v4.0

An adverse event is defined as the appearance of undesirable sign(s), symptom(s), or medical condition(s) that occur after patient’s signed informed consent has been obtained. Abnormal laboratory values or test results occurring after informed consent constitute adverse events only if they induce clinical signs or symptoms, are considered clinic

4.03

all patients