NCT04031612

Brief Summary

The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 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

Study Start

First participant enrolled

September 9, 2009

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

15 years

First QC Date

July 1, 2019

Last Update Submit

July 23, 2019

Conditions

Neoadjuvant Treatment in Breast Cancer

Keywords

Cancer; Breast, Neoadjuvant

Outcome Measures

Primary Outcomes (1)

  • Patient survival

    Overall survival and evolution over years

    5 years

Secondary Outcomes (1)

  • Collection of patient and treatment characteristics

    5 years

Study Arms (1)

Neoadjuvant Breast Cancer

Patients undergoing neoadjuvant therapy for breast cancer

Drug: Neoadjuvant therapy

Interventions

Neoadjuvant therapyDRUG

Neoadjuvant therapy

Neoadjuvant Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non metastatic breast cancer who received neoadjuvant chemotherapy prior to tumor surgery.

You may qualify if:

  • Women followed for breast cancer in Georges Francois Leclerc Center
  • Neoadjuvant chemotherapy
  • Age \>= 18

You may not qualify if:

  • Males
  • Metastatic breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodology, Biostatistics and Data Management Unit

Dijon, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

AURELIE BERTAUT, MD, PHD

CONTACT

+33 3 80 73 77 84ABertaut@cgfl.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 24, 2019

Study Start

September 9, 2009

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)