NCT04765124

Brief Summary

This study is a Non-Interventional Study (NIS) with secondary data usage. It is designed as a multi-center retrospective cohort study in which the data of adult locally advanced HER2-positive breast cancer patients, who are treated with as neoadjuvant therapy, who underwent breast surgery in participating centers, were taken from hospital records. The source population is academic or community oncology centers treating patients with breast cancer from Turkey. The study population is planned to be the subgroup of breast cancer patients, who are treated with trastuzumab plus taxane with or without pertuzumab as neoadjuvant therapy, and underwent breast surgery at the participating centers. The study is anticipated to include approximately 1500 patients from 20 sites.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

February 18, 2021

Last Update Submit

June 2, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate Pathologic Complete Response (pCR) rate

    pCR is defined as the absence of residual invasive disease on H\&E evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).

    8 months

Secondary Outcomes (3)

  • To evaluate 2 year Event-Free Survival (EFS)

    24 months

  • To evaluate 2-year Invasive Disease-Free Survival (IDFS)

    24 months

  • To evaluate the safety of trastuzumab plus taxane with or without pertuzumab in terms of grade 3, 4 and 5 according to CTCAE v.5.0

    8 months

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female patients diagnosed as breast cancer will be recruited
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The source population is academic or community oncology centers treating patients with breast cancer from Turkey. The study population is planned to be the subgroup of breast cancer patients, who are treated with trastuzumab plus taxane with or without pertuzumab as neoadjuvant therapy, and underwent breast surgery at the participating centers.

You may qualify if:

  • Female patients aged 18 years old and over
  • Patients diagnosed as histologically confirmed (IHC score of 3+ and/or positive by ISH) locally advanced HER2-positive breast cancer with breast surgery.
  • Patients who received as neoadjuvant therapy.

You may not qualify if:

  • Patients transferred from an other hospital should not be included, however, patients' data transferred to an other hospital will be collected till transfer time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ahmet Bilici, Prof

    Medipol University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Bilici, Prof

CONTACT

+905325280486ahmetknower@yahoo.com

Fatih Olmez, Prof

CONTACT

olmezof@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

April 29, 2021

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)