About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Chemoradiation
  • Chemoradiation

Treatment groups

858 Participants
are divided into 2 treatment groups

Locations

5
Homi Bhabha Cancer Hospital & Research Centre530053, VishkhapatnamAndhra Pradesh, India
Tata Memorial Centre400012, MumbaiMaharasthra, India
Homi Bhabha Cancer Hospital and Research Centre140901, New ChandigarhPunjab, India
Homi Bhabha Cancer Hospital, Sangrur148001, SangrurPunjab, India

Sponsors and collaborators

Dr. Tabassum Wadasadawala

Lead sponsor

Tata Memorial Centre

Sponsor institution