HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).

NCT04472845 | Recruiting DMC

• 1 other identifier: HYPART
• Study Type: interventional
• Target: 1,018
• Locations: 1 country
• Sites: 1

Brief Summary

We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy/16#/3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.

Conditions

Breast Cancer; Hypofractionation; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Loco-regional recurrence, Change is being assessed

  disease recurrence in the ipsilateral chest wall or regional lymph nodes from the time of randomization until the end of follow-up.

  5, 10 and 15 years

Secondary Outcomes (5)

• Disease-free survival, Change is being assessed

  5, 10 and 15 years

• Overall survival, Change is being assessed

  5, 10 and 15 years

• Acute radiation toxicity

  3 months

• Late adverse events, Change is being assessed

  5, 10 and 15 years

• Quality of life(QoL), Change is being assessed

  Baseline, 3 and 5 years

Study Arms (2)

1 week

EXPERIMENTAL

Radiotherapy dose to chest wall, axilla level III and supraclavicular fossa will be of 26Gy in 5 fractions over 1 week in the study arm. BCS patients will receive a sequential boost of 8Gy/2#/2days or simultaneous integrated boost(SIB) to a total dose of 34Gy.Supraclavicular fossa(SCF) and axilla level III will be treated in patients with T3-4 disease with lymphovascular invasion, grade 3 or N2 disease and T3-4 disease treated with neoadjuvant chemotherapy after adequate axillary dissection. Level I and II axilla will only be irradiated in patients with inadequate axillary dissection(\<10 lymph nodes). Internal mammary node (IMNs) radiation will be done in T3-4 central and inner quadrant lesions and patients with N2 disease. IMNs will be irradiated with a separate single field. The first five intercostal spaces will be included in the IMN target volume.

Radiation: 1 week RT

2 week

ACTIVE COMPARATOR

Radiotherapy dose to chest wall, axilla level III and supraclavicular fossa will be 34Gy in 10 fractions over 2 weeks in the control arm. BCS patients will receive a sequential boost of 8Gy/2#/2days or simultaneous integrated boost(SIB) to a total dose of 42 Gy.

Radiation: 2 week RT

Interventions

1 week RT RADIATION

RT will be delivered over 1 week

1 week

2 week RT RADIATION

RT will be delivered over 2 week

2 week

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with conformed invasive breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Female or male
• Invasive carcinoma of the breast
• Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)
• Concurrent trastuzumab and hormone therapy is allowed
• Axillary staging and/or dissection
• Complete microscopic excision of primary tumour
• pT3-4pN2-3 M0 disease
• Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy.
• Written informed consent
• Able to comply with follow-up

You may not qualify if:

• Supraclavicular node or internal mammary node or distant metastasis
• Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or(ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
• Contralateral breast cancer, including DCIS, irrespective of date of diagnosis
• Breast reconstruction using implants
• Pregnancy
• Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Budhi Singh Yadav

Chandigarh, 160012, India

RECRUITING

Related Publications (5)

• Yadav BS, Sharma SC, Singh R, Singh G, Kumar V. Postmastectomy radiation and survival in patients with breast cancer. J Cancer Res Ther. 2007 Oct-Dec;3(4):218-24. doi: 10.4103/0973-1482.38997.

  PMID: 18270397 BACKGROUND

• Yadav BS, Sharma SC, Singh R, Singh G. Patterns of relapse in locally advanced breast cancer treated with neoadjuvant chemotherapy followed by surgery and radiotherapy. J Cancer Res Ther. 2007 Apr-Jun;3(2):75-80. doi: 10.4103/0973-1482.34683.

  PMID: 17998727 BACKGROUND

• Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.

  PMID: 30711522 BACKGROUND

• Yadav BS, Goyal S, Dahiya D, Vias P, Gupta A, Datta A, Kataria V, Singh NR, Sharma R, Laroiya I, Irrinki S, P K, Pandey A. HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-Risk Patients With Breast Cancer (HYPART): Acute Toxicity Results. Int J Radiat Oncol Biol Phys. 2026 Jan 1;124(1):133-146. doi: 10.1016/j.ijrobp.2025.07.1447. Epub 2025 Aug 6.

  PMID: 40780546 DERIVED

• Yadav BS, Dahiya D, Kannan P, Goyal S, Laroiya I, Irrinki S, Singh NR, Sharma R. HYPofractionated Adjuvant RadioTherapy in 1 versus 2 weeks in high-risk patients with breast cancer (HYPART): a non-inferiority, open-label, phase III randomised trial. Trials. 2024 Jan 2;25(1):21. doi: 10.1186/s13063-023-07851-7.

  PMID: 38167339 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• BUDHI S YADAV

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BUDHI S YADAV, MD

CONTACT

9815981176; drbudhi@gmail.com

BUDHI S YADAV

CONTACT

9815981176; drbudhi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 15, 2020
• Study Start: March 30, 2021
• Primary Completion: August 20, 2023
• Study Completion (Estimated): August 20, 2028
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)