Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer

January 7, 2024 updated by: Nour Salah Khairallah, Assiut University

Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer and Implications for Follow up in Clinical Practice

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

Study Overview

Status

Not yet recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • breast cancer and NAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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