Patterns of Relapse After Neoadjuvant Chemotherapy in Bre... | NCT06210347

Studies
Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer

NCT06210347

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 18, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2024Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Jan 7, 2024

First Submission Date that Met QC Criteria

Jan 7, 2024

First Posted Date

Jan 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2024

Last Update Posted Date

Jan 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nour Salah Khairallah, Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer and Implications for Follow up in Clinical Practice, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to identify patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

Detailed Description

Neoadjuvant chemotherapy (NAC) is usually used to facilitate breast-conserving surgery and improve surgical outcomes for breast cancer patients [1]. In addition, NAC can help to eradicate micrometastatic disease and serve to test chemosensitivity while providing similar survival benefits to adjuvant chemotherapy [2-5] .

Pathologic complete response (pCR) after neoadjuvant chemotherapy is associated with superior survival outcomes, with higher rates of pCR in human epidermal growth factor receptor 2 positive (HER2+) and triple negative breast cancer (TNBC) subtypes compared to hormone receptor (HR)-positive subtypes [6-7] .

Patients who achieve pCR also remain at signifcant risk of relapse, with studies reporting 5-year disease-free survival (DFS) rates of 75-87% [2,8-10] . Retrospective study of 88 Japanese patients who achieved pCR reported a recurrence rate of 13.6% and all relapses occurred within 32 months from diagnosis [11].

There for, little is known about the patterns of relapse after NAC especially in the real world. There are currently no specific guidelines for post-treatment follow-up of patients treated with NAC and variations in practice exist. So, this study aims to evaluate the relapse risks in different subgroups of breast cancers treated with NAC and determine the associated time trends and patterns of relapse in these patients. These findings may potentially lead to the development of risk-adapted surveillance strategies for patients treated with NAC

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.	Patterns of relapse after Neoadjuvant Chemotherapy (NAC) in breast cancer patients to refine follow up recommendations.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients aged >= 18
Pathologically proved breast cancer
PS 0-1 (ECOG)
Patients indicated to receive NAC

Exclusion Criteria:

Patients with metastatic disease at diagnosis
Patients who did not undergo subsequent curative intent surgery
Those who received Neoadjuvant hormonal treatment
Those that had incomplete treatment information

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The study will be carried out at SECI between 2018 and 2022 . All cases with inclusion criteria will be included .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nour Salah, Master	Contact	0115 245 9725		dr.noursalah97@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36989610	Background	Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 2023 Apr 1;41(10):1795-1808. doi: 10.1200/JCO.22.02571.
11709566

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases