Breast Cancer FemaleHYPORTAdjuvantNCT03788213
One Week Versus Three Week in Adjuvant Radiotherapy in Breast Cancer
A study testing 3 week RT and 1 week RT in people with Breast Cancer Female, run by Tata Medical Center at 1 site in India.
Trial summary
Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- 3 week RT and 1 week RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteIndia
- Study dates
- 26 Mar 2019to 26 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed invasive breast cancers
- Age > 18 years
- ECOG performance status : 0 - 3
- Underwent curative intent surgery for the breast cancer with complete microscopic resection either in the form of a mastectomy or breast conservation surgery
- Adequate axillary clearance or a validated sentinel node biopsy procedure. For the purpose of this study, adequacy of the axillary clearance will be determined by a multidisciplinary tumor board and rationale for the decision documented in the case records. As a general guideline, at least 10 axillary lymph nodes need to be sampled for an axillary nodal dissection to be considered as adequate.
- Absence of distant metastases. Patients who have high risk breast cancer as defined by a Nottingham Prognostic Index (NPI) of > 5.4 will be considered for metastatic workup in the form of a 18 FDG PET CT. Alternatively, a CT scan of the thorax and whole abdomen, and a bone scan is also allowed. Metastatic workup will also be recommended in patients with AJCC 8 T3/T4 tumors at presentation, 4 or more nodes positive after surgery (pN2 or above). Patients with low or intermediate NPI will be considered for metastatic workup on a case by case basis. Metastatic workup will also be recommended for all patients undergoing neoadjuvant chemotherapy for locally advanced breast cancers.
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- Clear margins of resection for the breast primary as defined by absence tumor on ink in the specimen if a breast conservation has been performed or excision upto the deep fascia of the pectoralis major or skin.
- Adjuvant radiotherapy is indicated. The following patients will be considered as candidates to receive adjuvant radiotherapy:
- All patients after breast conservation surgery or after neoadjuvant chemotherapy
- Patients after mastectomy if any of the below:
- T3 - T4 tumors
- more than 3 axillary lymph nodes
- T0-T2 tumor with 0 - 3 axillary lymph nodes with a Cambridge Score of 3 or more.
- The SCF will be included in patients with axillary nodal involvement in pathology or in those patients who have undergone neoadjuvant chemotherapy. The internal mammary nodes will be included based on the institutional policy.
Who cannot join
- Presence of any one of the following will exclude the patient from participation in the study:
- Patients with pure ductal carcinomas in situ (in patients undergoing upfront surgery).
- Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
- Patients with metaplastic breast cancers
- Presence of pathologically proven residual supraclavicular nodal metastases or residual internal mammary lymphadenopathy at time of radiotherapy.
- Prior radiotherapy to the ipsilateral breast/chest wall or the mediastinum. Patients with synchronous / metachronous contralateral breast malignancies will be eligible for inclusion. Patients requiring bilateral breast radiotherapy are also eligible for inclusion.
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- Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- Patients planned for concurrent chemotherapy during radiation therapy. Concurrent hormonal therapy or targeted therapy using anti-HER2 agents is allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Sanjoy Chatterjee
Kolkata, West Bengal, 700160
Sanjoy Chatterjee, FRCR, 9038161825 ext. 7403, sanjoy.chatterjee@tmckolkata.com
Sanjoy Chatterjee, FRCR, 9038161825 ext. 7403, chatterjee72@hotmail.com
About this study
Official title: HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)
Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Recently studies have also demonstrated the safety and feasibility of simultaneous integrated boost in this setting. This randomized trial will investigate if a one-week course of hypofractionated breast radiotherapy is non-inferior to a three week course.
Aim: To determine if one-week schedule of adjuvant radiotherapy in breast cancer is non-inferior to a three week schedule.
Read more
Primary Objective: Locoregional Recurrence Rate (LRR) (Cumulative proportion of patients with locoregional recurrence) at 5 years
Secondary Objective:
- Overall survival (OS) (Time from randomization to death)
- Invasive Disease-free survival (iDFS) (Time from randomization to any invasive disease recurrence, death due to any cause or second invasive malignancy)
- Late adverse events (AE)
- Quality of Life (QoL)
Hypothesis:
- 1 week schedule will be non-inferior to a three week schedule for Locoregional Recurrence Rate
- 1 week schedule will be non-inferior to a three week schedule for OS
- 1 week schedule will be not result in worse late adverse events as compared to 3 week schedule
- Proportion of patients decrease in quality of life will not differ between the two arms at 12 months
Design: Open-label, parallel group, two arm, randomised, phase III, non-inferiority trial.
Population: Patients with breast cancer who need adjuvant radiotherapy after breast conservation or mastectomy.
Intervention: Patients will be randomized to 15 days or 5 days of radiotherapy to the whole breast or chest wall or reconstructed breast. Nodal radiation will be delivered as indicated. A simultaneous integrated boost (SIB) will be delivered to patients who need a tumor bed boost after breast cancer. The following dose schedules will be tested:
Control Group: 40 Gy in 15 fractions over 3 weeks (with SIB of 8 Gy)*
Test Group: 26 Gy in 5 fractions over 1 week (with SIB of 6 Gy).*
- Use of Sequential Boost is allowed in both arms if prespecified by the institution. If used dose is 12 Gy in 4 fractions in 1 week in both arms.
Outcomes and measures:
- LRR : Cumulative proportion of patients with ipsilateral Locoregional Recurrence after treatment at 5 years .
- OS: Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years.
- iDFS: Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer.Cumulative proportion reported at 5 years.
- AE: Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria
- QoL: Proportion of patients with a worse summary score in the EORTC QLQ C30 at 12 months post-treatment as compared to the baseline score.
- Conditions
- Breast Cancer Female
- Being tested
- 3 week RT, 1 week RT
- Keywords
- Hypo-fractionated Radiotherapy,, One week Radiotherapy, Simultaneous integrated boost, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 week RTRadiation
40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
1 week RTRadiation
26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
| Study group | Role | What they receive |
|---|---|---|
| 3 week RT | Active comparator | Adjuvant Radiotherapy delivered over 3 weeks Receives: Radiation: 3 week RT |
| 1 Week RT | Experimental | Adjuvant Radiotherapy delivered over 1 week Receives: Radiation: 1 week RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence Rate (LRR)
Cumulative proportion of patients with locoregional recurrence
Measured: 5 years
Secondary outcomes (4)
Overall Survival (OS )
Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years
Measured: 5 Years
Invasive Disease Free Survival ( iDFS )
Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer. Cumulative proportion reported at 5 years.
Measured: 5 Years
Adverse Event ( AE )
Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria
Measured: 5 Years
Quality of Life ( QoL )
Proportion of patients with a worse summary score in the health related quality of life as measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C30) at 12 months post-treatment as compared to the baseline score. The total summary score may range between 0 - 100 with higher scores indicating better health related quality of life. This score is the mean of the 13 of the 15 items of the EORTC QLQ C30 questionnaire which include the scores related to all the domains excepting the Global quality of life scale and Financial impact scale.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start26 Mar 2019
- Primary completion26 Mar 2029 (estimated)
- Study completion26 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, open-label, two arm, multicenter, randomized controlled trial with two parallel groups
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Kasturba Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788213
- Sponsor's protocol ID
- 2018/TMC/133/IRB/31
- Acronym
- HYPORTAdjuvant
- Status last verified
- Oct 2024
- First submitted
- 26 Dec 2018
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chakraborty S, Chatterjee S; Hyport Adjuvant Author Group. HYPORT adjuvant acute toxicity and patient dosimetry quality assurance results - Interim analysis. Radiother Oncol. 2022 Sep;174:59-68. doi: 10.1016/j.radonc.2022.07.003. Epub 2022 Jul 9.
PubMed 35817323Chatterjee S, Chakraborty S; HYPORT Adjuvant Author Group. Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)-study protocol for a multicentre, randomized phase III trial. Trials. 2020 Sep 30;21(1):819. doi: 10.1186/s13063-020-04751-y.
PubMed 32998747
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)
- ClinicalTrials.gov ID
- NCT03788213
- Acronym / sponsor ID
- HYPORTAdjuvant / 2018/TMC/133/IRB/31
- Conditions
- Breast Cancer Female
- Keywords
- Hypo-fractionated Radiotherapy,, One week Radiotherapy, Simultaneous integrated boost, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Tata Medical CenterUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Kasturba Medical College
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 26 Mar 2029 (estimated)
- Study completion
- 26 Mar 2029 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Recently studies have also demonstrated the safety and feasibility of simultaneous integrated boost in this setting. This randomized trial will investigate if a one-week course of hypofractionated breast radiotherapy is non-inferior to a three week course.
Aim: To determine if one-week schedule of adjuvant radiotherapy in breast cancer is non-inferior to a three week schedule.
Primary Objective: Locoregional Recurrence Rate (LRR) (Cumulative proportion of patients with locoregional recurrence) at 5 years
Secondary Objective:
- Overall survival (OS) (Time from randomization to death)
- Invasive Disease-free survival (iDFS) (Time from randomization to any invasive disease recurrence, death due to any cause or second invasive malignancy)
- Late adverse events (AE)
- Quality of Life (QoL)
Hypothesis:
- 1 week schedule will be non-inferior to a three week schedule for Locoregional Recurrence Rate
- 1 week schedule will be non-inferior to a three week schedule for OS
- 1 week schedule will be not result in worse late adverse events as compared to 3 week schedule
- Proportion of patients decrease in quality of life will not differ between the two arms at 12 months
Design: Open-label, parallel group, two arm, randomised, phase III, non-inferiority trial.
Population: Patients with breast cancer who need adjuvant radiotherapy after breast conservation or mastectomy.
Intervention: Patients will be randomized to 15 days or 5 days of radiotherapy to the whole breast or chest wall or reconstructed breast. Nodal radiation will be delivered as indicated. A simultaneous integrated boost (SIB) will be delivered to patients who need a tumor bed boost after breast cancer. The following dose schedules will be tested:
Control Group: 40 Gy in 15 fractions over 3 weeks (with SIB of 8 Gy)*
Test Group: 26 Gy in 5 fractions over 1 week (with SIB of 6 Gy).*
- Use of Sequential Boost is allowed in both arms if prespecified by the institution. If used dose is 12 Gy in 4 fractions in 1 week in both arms.
Outcomes and measures:
- LRR : Cumulative proportion of patients with ipsilateral Locoregional Recurrence after treatment at 5 years .
- OS: Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years.
- iDFS: Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer.Cumulative proportion reported at 5 years.
- AE: Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria
- QoL: Proportion of patients with a worse summary score in the EORTC QLQ C30 at 12 months post-treatment as compared to the baseline score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, controlled, open-label, two arm, multicenter, randomized controlled trial with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| 3 week RT | Active comparator | Radiation: 3 week RTAdjuvant Radiotherapy delivered over 3 weeks |
| 1 Week RT | Experimental | Radiation: 1 week RTAdjuvant Radiotherapy delivered over 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed invasive breast cancers
- Age > 18 years
- ECOG performance status : 0 - 3
- Underwent curative intent surgery for the breast cancer with complete microscopic resection either in the form of a mastectomy or breast conservation surgery
- Adequate axillary clearance or a validated sentinel node biopsy procedure. For the purpose of this study, adequacy of the axillary clearance will be determined by a multidisciplinary tumor board and rationale for the decision documented in the case records. As a general guideline, at least 10 axillary lymph nodes need to be sampled for an axillary nodal dissection to be considered as adequate.
Key exclusion criteria (9 listed)
- Presence of any one of the following will exclude the patient from participation in the study:
- Patients with pure ductal carcinomas in situ (in patients undergoing upfront surgery).
- Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
- Patients with metaplastic breast cancers
- Presence of pathologically proven residual supraclavicular nodal metastases or residual internal mammary lymphadenopathy at time of radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 week RT40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT. | Radiation | 3 week RT |
| 1 week RT26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT. | Radiation | 1 Week RT |
Primary outcome
Locoregional Recurrence Rate (LRR)
Time frame: 5 years
Cumulative proportion of patients with locoregional recurrence
4 secondary outcomes
Overall Survival (OS )
Time frame: 5 Years
Invasive Disease Free Survival ( iDFS )
Time frame: 5 Years
Adverse Event ( AE )
Time frame: 5 Years
Quality of Life ( QoL )
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 35817323Chakraborty S, Chatterjee S; Hyport Adjuvant Author Group. HYPORT adjuvant acute toxicity and patient dosimetry quality assurance results - Interim analysis. Radiother Oncol. 2022 Sep;174:59-68. doi: 10.1016/j.radonc.2022.07.003. Epub 2022 Jul 9.
- Derived from this study: PubMed 32998747Chatterjee S, Chakraborty S; HYPORT Adjuvant Author Group. Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)-study protocol for a multicentre, randomized phase III trial. Trials. 2020 Sep 30;21(1):819. doi: 10.1186/s13063-020-04751-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 week RT and 1 week RT in people with Breast Cancer Female, run by Tata Medical Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjoy Chatterjee, FRCR (9038161825 ext. 7403, sanjoy.chatterjee@tmckolkata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Recurrence Rate (LRR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.