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CompletedNCT03669497HYPORT-BUpdated Dec 22, 2023

Hypo-Fractionated Radiotherapy in Breast Cancer

An interventional study of Hypo fractionated whole breast radiotherapy in Breast Cancer, Advanced Breast Cancer and Metastatic Breast Cancer, sponsored by Tata Medical Center. Completed at 1 site in India. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Tata Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Breast Cancer

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Keywords

  • Palliative Radiotherapy
  • Hypo-fractionated Radiotherapy
  • Simultaneous integrated boost
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 33 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Tata Medical Center is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Breast reconstruction using implants

    • Concurrent cyto-toxic chemotherapy
    • Prior radiation to the chest wall / breast
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Hypo fractionated radiotherapy

    Hypo fractionated whole breast radiotherapy with simultaneous integrated boost to the tumour

    Radiation: Hypo fractionated whole breast radiotherapy

Interventions

  • RadiationHypo 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. Response

    To assess the response 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria

    Time frame: 3 months

07

Study locations

1 site
  • Sanjoy Chatterjee
    Kolkata, West Bengal 700160, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03669497
Lead sponsor
Tata Medical Center
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Jan 2, 2018
Primary completion
Dec 2, 2020
Completion
Sep 6, 2021
Last update
Dec 22, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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