AzTrials
AzTrials

Breast CancerPhase 2NCT04224922

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 Phase 2 study testing Paclitaxel, Carboplatinum and Epirubicin in people with Breast Cancer, run by Universitair Ziekenhuis Brussel at 18 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Paclitaxel, Carboplatinum and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
18 sitesBelgium
Study dates
May 2015to May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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)

Who cannot join

  • 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 locations and contacts

18 sites in 1 country.

18 sites in 1 country

Belgium18 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, 9300

  • Cliniques Sud Luxembourg

    Arlon, 6700

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • AZ klina

    Brasschaat, 2930

  • St Lucas

    Bruges, 8310

  • Institut Jules Bordet

    Brussels, 1000

  • Universitaire Ziekenhuis Antwerpen

    Edegem, 2650

  • AZ Maria Middelares

    Ghent, 9000

  • AZ St Lucas

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHR Citadelle

    Liège, 4000

  • CHU Sart-Tilman

    Liège, 4000

  • CMSE

    Namur, 5000

  • Clinique st Pierre

    Ottignies, 1340

  • CHWAPI

    Tournai, 7500

  • CHR Verviers

    Verviers, 4800

  • CHU Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

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

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
Being tested
Paclitaxel, Carboplatinum, Epirubicin, Cyclophosphamide
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04224922
Study groupRoleWhat they receive
single-armExperimentalweekly 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
Receives: Drug: Paclitaxel; Drug: Carboplatinum; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 20 weeks

Secondary outcomes (9)

  1. Evaluation of tumor infiltrating lymphocytes on the residual tumor

    Histopathological analysis of the lymphocyte infiltrate is performed on hematoxylin and eosin- stained sections of the core biopsies and afterwords on the resection specimen after neoadjuvant chemotherapy. Ancillary techniques and immunohistochemistry have no additional value upon this date, and are not recommanded. The overall assessment has to be made for the whole tumor area, regardless of hot spots. All mononuclear cells including lymphocytes and plasma cells should be scored (granulocytes and other polymorphonuclear leukocytes are excluded). The quantitative assessment of other mononuclear cells such as dendritic cells and macrophages is currently not recommended. TILs should be reported for the intratumoral lymphocytes (as first proposed by Denkert in 2010). Stromal lymphocytes (Str-Ly) are defined as the percentage of tumor stroma area that contains a lymphocytic infiltrate without direct contact to tumor cells.

    Measured: 20 weeks

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

    Measured: 20 weeks

  3. Evaluation of the drug delivery

    Patient compliance for paclitaxel and carboplatin and for epirubicin and cyclophosphamide will be assessed by the investigator and/or study personnel at each patient visit. To accurately determine the patient's drug exposure throughout the study, the following information must be reported on the Drug Administration Record CRF pages and in the source document.

    Planned dose administration, Actual total daily dose administrated, Regimen, Start and end date of drug administration, Dose change, Reason for dose change

    Measured: 20 weeks

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

    Measured: 20 weeks

  5. Evaluation of breast-conserving surgery rate

    Measured: 20 weeks

  6. Evaluation of progression free survival

    Measured: 20 weeks

  7. Evaluation of overall survival

    Measured: 20 weeks

  8. Evaluation of percentage of patients with BRCA1 or BRCA2 in this population.

    Measured: 20 weeks

  9. genome analysis on tissue samples

    Tumor tissue samples (FFPE) for genetic research will be obtained from consenting patients both at screening and at surgery.

    Genome analysis will be performed on (1) DNA extracted from EDTA blood (10ml) collected at the start of the treatment and (2) on DNA extracted from FFPE tumor tissue collected before the start of the neoadjuvant chemotherapy and after surgery.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study startMay 2015
  3. Primary completionJul 2016
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04224922
Sponsor's protocol ID
BSMO-2014-01
Status last verified
Jan 2020
First submitted
7 Jan 2020
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatinum and Epirubicin in people with Breast Cancer, run by Universitair Ziekenhuis Brussel at 18 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

-The rate of pCR in the breast and axilla (ypT0/is, ypN0) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04224922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in