Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Phase 3

Recruiting

• Conditions: Invasive Breast Cancer; Stage III Breast Cancer; Stage IIB Breast Cancer
• Interventions: Drug: Chemoradiation

• Registration Number: NCT06926543
• Lead Sponsor: Dr. Tabassum Wadasadawala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Study First Submitted: 2025-02-14
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Primary Completion: 2031-05
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 858

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Standard Arm	Chemoradiation	Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
Arm B: Experimental arm	Chemoradiation	Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy

Primary Outcome Measures

Name	Time	Method
Study the 3-year Disease Free Survival.	From enrollment to 3 years after treatment at six months intervals.

Secondary Outcome Measures

Name	Time	Method
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.	From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.	All patients who undergo breast conservation surgery will be eligible for this sub-study in which we intend to collect frontal breast photographs for objective assessment of breast cosmesis.
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.	From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.	As patients in the intervention arm will complete their treatment at least 6-8 weeks before the patients in the standard arm, it will have huge impact on the expenditure that the patient bears for staying, food as well as transport to the hospital. Hence, we would like to collect data pertaining to patient's daily expenditure during their adjuvant treatment.
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods	From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years	As the breast cancer treatment increases the risk of swelling in the upper limb, we would like to assess for the same. This will help us to diagnose lymphedema at an early stage and will be able to treat it more effectively.
Overall survival (OS)outcome assessment in the two arms.	From enrollment to 5 years after treatment at 6 months intervals
Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.	From enrollment to 5 years after treatment at 6 months intervals
Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.	From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.

Trial Locations

Locations (5)

Homi Bhabha Cancer Hospital & Research Centre; 🇮🇳 Vishkhapatnam, Andhra Pradesh, India

Tata Memorial Centre; 🇮🇳 Mumbai, Maharasthra, India

Homi Bhabha Cancer Hospital and Research Centre; 🇮🇳 New Chandigarh, Punjab, India

Homi Bhabha Cancer Hospital, Sangrur; 🇮🇳 Sangrur, Punjab, India

Mahamana Pandit Madan Mohan Malviya Cancer Centre; 🇮🇳 Varanasi, Uttar Pradesh, India