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

A

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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