Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy (CONCERT)

  • STATUS
    Recruiting
  • End date
    May 2, 2031
  • participants needed
    858
  • sponsor
    Dr. Tabassum Wadasadawala
Send
Updated on 2 May 2025
See if I qualify

Summary

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:

  1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
  2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
  3. What are each treatment approach's financial costs?

Researchers will compare the following to groups:

Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation.

and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy.

Participants are going to:

  1. Get the usual chemotherapy (taxanes and/or anthracyclines).
  2. Receive radiation therapy for three to four weeks.
  3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Details
Condition Invasive Breast Cancer, Stage III Breast Cancer, Stage IIB Breast Cancer
Age 18years or above
Clinical Study IdentifierNCT06926543
SponsorDr. Tabassum Wadasadawala
Last Modified on2 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Pathologically confirmed invasive breast cancer
Stage IIB-III invasive breast cancer (AJCC 8th edition)
Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
Patients fit to receive adjuvant chemotherapy and radiotherapy
Age > 18 years

Exclusion Criteria

Hypersensitivity to taxanes
Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
Unable or unwilling for regular follow up
Bilateral tumour needed RT to both sides
Patients planned for RT to oligometastatic sites
Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints)
Pregnant patient
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.