Palliative breast radiotherapy in advanced incurable breast cancer

HYPO-FRACTIONATED RADIOTHERAPY SCHEDULE OF 35GY IN 10 FRACTIONS IN ADVANCED INCURABLE BREAST CANCER: A PROSPECTIVE PHASE I/II STUDY - HYPORT

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/12/006407

Enrollment

Registered

2015-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast Cancer

Interventions

Intervention1: Radiation therapy: HYPO-FRACTIONATED RADIOTHERAPY SCHEDULE OF 35GY IN 10 FRACTIONS IN ADVANCED INCURABLE BREAST CANCER Intervention2: BIOPSY: Core biopsy from tumour and epidermis punch

Eligibility

Inclusion criteria

Inclusion criteria: 1.ECOG-0,1,2 2.Locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumor board. 3.Metastatic breast cancer patients:awaiting palliative locoregional radiotherapy for symptom(pain bleeding, ulceration, impending fungation)control. 4.who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy.

Exclusion criteria

Exclusion criteria: 1.Breast reconstruction using implants 2.Concurrent cytotoxic chemotherapy

Design outcomes

Primary

Measure	Time frame
To assess the toxicity using CTCAE version 4 and LENT SOMA toxicity criteria, in advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35GY in 10 fractions rather than 15 fractionsTimepoint: Acute toxicity will be assessed weekly during radiotherapy then monthy for 1st three month after completion of radiotherapy.	—

Secondary

Measure	Time frame
To assess the response of advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35GY in 10fractions, 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria To assess the impact of hypofractionated breast radiotherapy schedule of 35GY in 10 fractions over 2 weeks on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire Timepoint: Response assessment 3 month after completion of radiotherapy with clinical assessment and PET-CT scan QOL assessment just after completion and 3 months after completion of radiotherapy, then at 6 months and 1 year after completion of radiotherapy.	—

Measure

Time frame

To assess the response of advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35GY in 10fractions, 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria To assess the impact of hypofractionated breast radiotherapy schedule of 35GY in 10 fractions over 2 weeks on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire Timepoint: Response assessment 3 month after completion of radiotherapy with clinical assessment and PET-CT scan QOL assessment just after completion and 3 months after completion of radiotherapy, then at 6 months and 1 year after completion of radiotherapy.

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Countries

India

Contacts

Public ContactDr Animesh Saha

Tata Medical Center

mesh.vicky@gmail.com9883274996

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026