Clinical trial · Interventional
Palliative Hypofractionated Radiotherapy in Advanced Incurable Breast Cancer
Hypofractionated Radiotherapy Schedule of 35 Gray in 10 Fractions in Advanced Incurable Breast Cancer: A Prospective Phase I/II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective phase I/II study to assess the clinical toxicity and investigate the clinical response of breast cancers to a 10 fraction hypofractionated course of radiation therapy in advanced incurable breast cancer patients. This study would also investigate the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients. An intervention radiation therapy dose of 35 Gray in 10 fractions over 2 weeks, 5 fractions per week, 1 fraction per day will be studied within this clinical trial. Primary objective of the study is to assess the toxicity using CTCAE version 4 and LENTSOMA toxicity criteria, in advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35 GY in 10 fractions . Secondary objectives are 1. response rate after radiotherapy measured using the PERCIST criteria at 3 months. 2. Change in quality of life measured using trial outcome index (TOI) at 2 weeks after radiotherapy. 3. Measure the change in PHQ4 score at 2 weeks after radiotherapy. Additionally to assess the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients and to biobank tissue and blood for future radiobiology tests. A total of 30 patients will be recruited in this study. Among these 30 patients at least 10 patients will be recruited with left sided breast cancer on which feasibility of voluntary breath hold technique for heart sparing will be tested. Patient will be followed up weekly during radiotherapy, then monthly for 1st three months, then 3 monthly for two years, then 6 monthly for next 3 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Breast Stage IV | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm study
- description
- Hypofractionated Radiotherapy Schedule of 35 GY in 10 fractions is being administered in advanced Incurable Breast Cancer for female patients
- interventionNames
- Radiation: Hypofractionated Radiotherapy
Primary outcomes (1)
- measure
- Proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity
- timeFrame
- 2 Years
- description
- The proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity related to radiotherapy will be assesed. This will include toxicities like radiation fibrosis, lymphedema, pneumonitis and brachial plexopathy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (all of 1-4) 1.Invasive carcinoma of the breast 2.ECOG performance Status:0,I,II 3a.Locally Advanced breast cancer which is not amenable to curative surgery as decided by Multidisciplinary tumor board OR 3b.Metastatic breast cancer patients: i) who are awaiting palliative locoregional radiotherapy for symptom (pain,bleeding,ulceration) ii) who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy 4.Able to give consent Exclusion Criteria: 1. Breast reconstruction using implants 2. Concurrent cyto-toxic chemotherapy -
References
Publications (2)
- BACKGROUNDClarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7. PMID 16360786
- BACKGROUNDDarby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825. PMID 23484825