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

AZ-VUB

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Carboplatinum

Study type: Interventional

Funder types: Other

Identifiers

NCT04224922

BSMO-2014-01

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

single-arm

Experimental group

Description:

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

Treatment:

Drug: Carboplatinum

Drug: Cyclophosphamide

Drug: Epirubicin

Drug: Paclitaxel