Hypo-Fractionated Radiotherapy in Breast Cancer (HYPORT-B)

Hypo-fractionated Radiotherapy Schedule of 26 GY in 5 Fractions With Simultaneous Integrated Boost (6 GY) in Advanced Incurable Breast Cancer: A Prospective Phase I/II Study (HYPORT-B).

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Radiation: Hypo fractionated whole breast radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjoy Chatterjee, FRCR; Phone Number: 7405 9038161825; Email: chatterjee72@hotmail.com

Study Locations

• India
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Sanjoy Chatterjee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years

  • Female
  • Invasive carcinoma of the breast
  • ECOG performance status 0-2
  • Locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumour board.

  • Metastatic breast cancer patients:

    • Who are awaiting palliative locoregional radiotherapy for symptom (pain bleeding, ulceration, impending fungation) control.
    • Who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy
  • Able to give informed consent

Exclusion Criteria:

• Breast reconstruction using implants

  • Concurrent cyto-toxic chemotherapy
  • Prior radiation to the chest wall / breast

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypo fractionated radiotherapy; Hypo fractionated whole breast radiotherapy with simultaneous integrated boost to the tumour	Radiation: Hypo fractionated whole breast radiotherapy; Hypo fractionated radiotherapy to the whole breast and SCF to a dose of 26 GY in 5 fractions with simultaneous integrated boost in advanced incurable breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity (CTCAE v 4.03)	Proportion of patients with Grade 3 or more toxicity at 3 months evaluated as per the CTCAE v 4.03 criteria.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response	To assess the response 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria	3 months

Collaborators and Investigators

• Sponsor: Tata Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Simultaneous integrated boost; Palliative Radiotherapy; Hypo-fractionated Radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EC/TMC/108/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No