NCT03669497: HYPORT-B

Hypo-Fractionated Radiotherapy in Breast Cancer

Completed NA Last updated 22 December 2023

What this trial tests

NA trial testing Hypo fractionated whole breast radiotherapy in Breast Cancer in 33 participants. Completed in 6 September 2021.

Timeline

2 January 2018

Primary endpoint
2 December 2020

6 September 2021

Quick facts

Lead sponsor	Tata Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	2 January 2018
Primary completion	2 December 2020
Estimated completion	6 September 2021
Sites	1 location across India

Drugs / interventions tested

• Hypo fractionated whole breast radiotherapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →
• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Tata Medical Center

Who can join

18 and older, female only, with Breast Cancer or Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective interventional phase I/II study which will be done at Tata Medical Centre, Kolkata. Total 30 eligible female patients, ≥18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. Once consented, all patients will have regional baseline PET-CT scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. Planning Ct scan will then be taken, with standard planning CT scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. All patients will be treated with hypo-fractionated radiotherapy with schedule of 26Gy on 5 Fractions over 1 week with 6Gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. All patients will be assessed weekly during course of radiotherapy. The toxicity will be assessed using CTCAE version 4 and LENT SOMA toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. Response evaluation will be done clinically and by regional PET CT scan using PERSIST criteria in 3 months after completion of radiotherapy. After completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.