A Phase 3 interventional study of Chemoradiation and Chemoradiation in Invasive Breast Cancer, Stage III Breast Cancer and Stage IIB Breast Cancer, sponsored by Dr. Tabassum Wadasadawala. Recruiting at 5 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Dr. Tabassum Wadasadawala · Phase 3, Interventional, and Treatment
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:
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:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 858 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Dr. Tabassum Wadasadawala as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
Drug: Chemoradiation
Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy
Drug: Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
Study the 3-year Disease Free Survival.
Time frame: From enrollment to 3 years after treatment at six months intervals.
Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.
Time frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
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.
Time frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
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.
Time frame: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
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.
Time frame: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
Overall survival (OS)outcome assessment in the two arms.
Time frame: From enrollment to 5 years after treatment at 6 months intervals
Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.
Time frame: From enrollment to 5 years after treatment at 6 months intervals
Plan to share: No
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