NCT06631066

Brief Summary

This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

August 13, 2024

Last Update Submit

October 6, 2024

Conditions

Breast Cancer Female

Keywords

preoperative radiotherapylocally advanced breast cancerpathologic response

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response rates

    the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system

    1 week postoperative

Secondary Outcomes (1)

  • acute radiation toxicity

    during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks

Study Arms (2)

neoadjuvant chemotherapy arm

NO INTERVENTION

The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines. post systemic treatment imaging will be done to assess the response, followed by surgery as indicated. Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated. Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics.

Neoadjuvant chemoradiation arm

EXPERIMENTAL

The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines.

Radiation: neoadjuvant chemoradiation

Interventions

neoadjuvant chemoradiationRADIATION

Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.

Neoadjuvant chemoradiation arm

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients.
  • Age: 21 years or older.
  • ECOG performance status (PS) score 0 to 2.
  • Locally advanced tumors (stage IIIA or above) of any subtype.
  • Early breast cancer of the HER2+ or TNBC subtype when:
  • Node-negative, T2 or T3.
  • Node-positive, any T stage.

You may not qualify if:

  • Patients initially presenting with metastatic breast cancer.
  • Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
  • Inflammatory breast cancer (T4d) patients.
  • Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
  • History of previous ipsilateral breast surgery.
  • Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

Related Publications (2)

  • Ward J, Ho K, Ike C, Wood SH, Thiruchelvam PTR, Khan AA, Leff DR. Pre-operative chemoradiotherapy followed by mastectomy and breast reconstruction-A systematic review of clinical, oncological, reconstructive and aesthetic outcomes. J Plast Reconstr Aesthet Surg. 2024 Sep;96:242-253. doi: 10.1016/j.bjps.2024.07.022. Epub 2024 Jul 15.

    PMID: 39106546BACKGROUND

  • O' Halloran N, McVeigh T, Martin J, Keane M, Lowery A, Kerin M. Neoadjuvant chemoradiation and breast reconstruction: the potential for improved outcomes in the treatment of breast cancer. Ir J Med Sci. 2019 Feb;188(1):75-83. doi: 10.1007/s11845-018-1846-6. Epub 2018 Jun 14.

    PMID: 29948462BACKGROUND

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Medhat El Sebaie, Professor

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 13, 2024

First Posted

October 8, 2024

Study Start

October 20, 2021

Primary Completion

October 10, 2023

Study Completion

July 15, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)