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

NCT04224922 | Completed Phase 2 DMC

• 1 other identifier: BSMO-2014-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 18

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• -The rate of pCR in the breast and axilla (ypT0/is, ypN0)

  20 weeks

Secondary Outcomes (9)

• Evaluation of tumor infiltrating lymphocytes on the residual tumor

  20 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03

  20 weeks

• Evaluation of the drug delivery

  20 weeks

• Evaluation of clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla.

  20 weeks

• Evaluation of breast-conserving surgery rate

  20 weeks

Study Arms (1)

single-arm

EXPERIMENTAL

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

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

Interventions

Paclitaxel DRUG

single-arm

Carboplatinum DRUG

single-arm

Epirubicin DRUG

single-arm

Cyclophosphamide DRUG

single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ-VUB: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (18)

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

Cliniques Sud Luxembourg

Arlon, 6700, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ klina

Brasschaat, 2930, Belgium

Location

St Lucas

Bruges, 8310, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitaire Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

AZ St Lucas

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

CMSE

Namur, 5000, Belgium

Location

Clinique st Pierre

Ottignies, 1340, Belgium

Location

CHWAPI

Tournai, 7500, Belgium

Location

CHR Verviers

Verviers, 4800, Belgium

Location

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Christel Fontaine, Dr.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

BE (18)