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Breast CancerPhase 3HARVESTNCT03829553

Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

A Phase 3 study testing Hypofractionated radiotherapy and Conventional radiotherapy in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI)… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Hypofractionated radiotherapy and Conventional radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
801 participants
Where
1 siteChina
Study dates
21 Feb 2019to Dec 2027
Phase
Phase 3
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old
  • unilateral histologically confirmed invasive breast carcinoma of pT1-3
  • breast conservation surgery or mastectomy
  • Breast reconstruction is allowed
  • histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
  • Life expectancy of >5 years
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  • A minimum negative surgical margin width of >2mm
  • Karnofsky Performance Status ≥80
  • Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
  • Written informed consent

Who cannot join

  • Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
  • Pregnant or lactating
  • Severe non-neoplastic medical comorbidities
  • Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
  • Simultaneous contralateral breast cancer
  • Previous RT to thoracic and/or axillary, cervical region
Show all 11Show fewer
  • Active collagen vascular disease
  • Evidence of distant metastatic disease and/or T4 disease
  • Notes for exlusion criteria:
  • Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
  • Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jia-Yi Chen contact

+86-021-64370045 ext. 602400

chenjiayi0188@aliyun.com

China1 site, 1 recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Jia-Yi Chen, M.D., +86-021-64370045 ext. 602400, chenjiayi0188@aliyun.com

    Jia-Yi Chen, M.D, +86-021-64370045 ext. 602400, chenjiayi0188@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

Read the detailed description

Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence. Patients will be followed at least 5 years after radiotherapy to evaluated over survival, distant metastasis, toxicity and life quality.

Conditions
Breast Cancer
Being tested
Hypofractionated radiotherapy, Conventional radiotherapy
Keywords
regional nodal irradiation, IMRT, Hypofractionated radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated radiotherapyRadiation

    Also called Experimental Arm

    4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

  • Conventional radiotherapyRadiation

    Also called Active Comparator Arm

    5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Study groups in NCT03829553
Study groupRoleWhat they receive
Hypofractionated radiotherapyExperimentalPatients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery
Receives: Radiation: Hypofractionated radiotherapy
Conventional radiotherapyActive comparatorPatients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
Receives: Radiation: Conventional radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Locoregional recurrence (LRR)

    any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN)

    Measured: 5 years

Secondary outcomes (7)

  1. Distant metastasis free survival (DMFS)

    the time from the date of randomization to any recurrence of tumor at distant sites or death from any cause.

    Measured: 5 years

  2. Invasive recurrence-free survival (IRFS)

    the time from the date of randomization to any invasive recurrence of tumor, distant metastases or death from any cause and second invasive primaries, including invasive neoplasms of the breast.

    Measured: 5 year

  3. over survival (OS)

    the time from the date of randomization to the date of death from any cause or end of the follow-up.

    Measured: 5 years

  4. Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale

    The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast.

    Measured: 5 years

  5. Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity

    within time from beginning of RT to 6 months after completion of RT assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: 6 months

  6. Number of Participants with ≥Grade1 Late Radiation-induced Toxicity

    within time from 6 months after completion of RT to 5 years after completion of RT assessed according to the RTOG/ European Organization for Research on Treatment of Cancer (EORTC） Late Radiation Morbidity Scoring Schema and CTCAE version 3.0

    Measured: 5 years

  7. Reconstruction complications

    number of participants with any reconstruction complications (flap necrosis, capsular contracture, infection, loss of implant/expander or flaps, et al) and the interval between the RT and reconstruction complications will be recorded. Patient reported outcome with reconstruction will be evaluated by Breast-Q questionnaires before RT and 12 months after RT.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start21 Feb 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
801 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829553
Sponsor's protocol ID
RJBC-HFRNI
Acronym
HARVEST
Status last verified
May 2022
First submitted
27 Jan 2019
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xie J, Xu F, Zhao Y, Cai G, Lin X, Zhu Q, Lin Q, Yao Y, Xu C, Cai R, Wang S, Tang X, Chen C, Zheng S, Chen M, Chen M, Qian X, Shen C, Li J, Xu H, Xu F, Han Y, Li M, Ou D, Shen KW, Qi WX, Cao L, Huang X, Chen J. Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial. BMJ Open. 2022 Sep 1;12(9):e062034. doi: 10.1136/bmjopen-2022-062034.

    PubMed 36581983

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypofractionated radiotherapy and Conventional radiotherapy in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.

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 10 inclusion and 11 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 2 Jun 2022. 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 China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jia-Yi Chen (+86-021-64370045 ext. 602400, chenjiayi0188@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locoregional recurrence (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 NCT03829553, which also lists 1 linked publication.

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 2 Jun 2022.

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