Clinical trial NCT04224922: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AZ-VUB
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Universitair Ziekenhuis Brussel
First posted: 2020-01-13
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: -The rate of pCR in the breast and axilla (ypT0/is, ypN0)
timeFrame: 20 weeks
Secondary outcomes:
measure: Evaluation of tumor infiltrating lymphocytes on the residual tumor
timeFrame: 20 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03
timeFrame: 20 weeks
measure: Evaluation of the drug delivery
timeFrame: 20 weeks
measure: Evaluation of clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla.
timeFrame: 20 weeks
measure: Evaluation of breast-conserving surgery rate
timeFrame: 20 weeks
measure: Evaluation of progression free survival
timeFrame: 20 weeks
measure: Evaluation of overall survival
timeFrame: 20 weeks
measure: Evaluation of percentage of patients with BRCA1 or BRCA2 in this population.
timeFrame: 20 weeks
measure: genome analysis on tissue samples
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Arlon
country: Belgium
facility: Cliniques Sud Luxembourg
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brasschaat
country: Belgium
facility: AZ klina
city: Brugge
country: Belgium
facility: St Lucas
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: Universitaire Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ St Lucas
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Namur
country: Belgium
facility: CMSE
city: Ottignies
country: Belgium
facility: Clinique st Pierre
city: Tournai
country: Belgium
facility: CHWAPI
city: Verviers
country: Belgium
facility: CHR Verviers
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Christel Fontaine, Dr.
role: PRINCIPAL_INVESTIGATOR
References: