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Completed

NCT Number: NCT06631066

Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients

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

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Key information

Conditions

Breast Cancer Female

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, Egypt

About this study

A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.

The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

neoadjuvant chemoradiation

Radiation

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.

Primary outcomes

  1. pathologic complete response rates

    Time frame: 1 week postoperative

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

Secondary outcomes

  1. acute radiation toxicity

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

    radiation therapy oncology group (RTOG) acute morbidity score

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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