Recruiting

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

ClinicalTrials.gov IDNCT06926543

PhasePHASE3

Enrollment858

SponsorDr. Tabassum Wadasadawala

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Invasive Breast Cancer, Stage III Breast Cancer, Stage IIB Breast Cancer

About this study

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.

Interventions

Drug: Chemoradiation — This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Drug: Chemoradiation — This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.

Primary outcomes

Study the 3-year Disease Free Survival. (From enrollment to 3 years after treatment at six months intervals.)

Eligibility information

Inclusion Criteria: 1. Pathologically confirmed invasive breast cancer 2. Stage IIB-III invasive breast cancer (AJCC 8th edition) 3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy 4. Patients fit to receive adjuvant chemotherapy and radiotherapy 5. Age \> 18 years Exclusion Criteria: 1. Hypersensitivity to taxanes 2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting) 3. Unable or unwilling for regular follow up 4. Bilateral tumour needed RT to both sides 5. Patients planned for RT to oligometastatic sites 6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints). 7. Pregnant patient

Study locations

Homi Bhabha Cancer Hospital & Research Centre, Vishkhapatnam, Andhra Pradesh 530053 India
Tata Memorial Centre, Mumbai, Maharasthra 400012 India
Homi Bhabha Cancer Hospital and Research Centre, New Chandigarh, Punjab 140901 India
Homi Bhabha Cancer Hospital, Sangrur, Sangrur, Punjab 148001 India
Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi, Uttar Pradesh 221005 India

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.