Breast Cancer Clinical Trial
— HYPARTOfficial title:
HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.
NCT number | NCT04472845 |
Other study ID # | HYPART |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 30, 2021 |
Est. completion date | August 20, 2028 |
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.
Status | Recruiting |
Enrollment | 1018 |
Est. completion date | August 20, 2028 |
Est. primary completion date | August 20, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years 2. Female or male 3. Invasive carcinoma of the breast 4. 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) 5. Concurrent trastuzumab and hormone therapy is allowed 6. Axillary staging and/or dissection 7. Complete microscopic excision of primary tumour 8. pT3-4pN2-3 M0 disease 9. Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy. 10. Written informed consent 11. Able to comply with follow-up Exclusion Criteria: 1. Supraclavicular node or internal mammary node or distant metastasis 2. 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 3. Contralateral breast cancer, including DCIS, irrespective of date of diagnosis 4. Breast reconstruction using implants 5. Pregnancy 6. Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed) |
Country | Name | City | State |
---|---|---|---|
India | Budhi Singh Yadav | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Disease-free survival, Change is being assessed | locoregional recurrence, distant metastasis, or death from any cause from the time of randomisation until the end of follow-up. | 5, 10 and 15 years | |
Secondary | Overall survival, Change is being assessed | death from any cause from the time of randomisation until the end of follow-up | 5, 10 and 15 years | |
Secondary | Acute radiation toxicity | Any loco-regional toxicity assessed and scaled according to the RTOG grading system. | 3 months | |
Secondary | Late adverse events, Change is being assessed | Any adverse event occurring after 6 months of RT | 5, 10 and 15 years | |
Secondary | Quality of life(QoL), Change is being assessed | QoL will be assessed with EORTC QLQ -30. The QLQ-C30 is composed of both multi-item scales and single-item measures, as well as five functional scales, three symptom scales, a global health status/QoL scale, and six single items. The scores must be averaged and linearly transformed to obtain a range of scores from 0 to 100, with a higher score representing a greater response level. | Baseline, 3 and 5 years |
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