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Breast Cancer FemaleHYPOG-01NCT03127995

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

A study testing HYPOFRACTIONATED and NORMOFRACTIONATED in people with Breast Cancer Female, run by UNICANCER at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas… Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
HYPOFRACTIONATED and NORMOFRACTIONATED
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,265 participants
Where
28 sitesFrance
Study dates
Sep 2016to Sep 2030
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 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status.
  • ECOG 0-2
  • Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN.
  • Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted.
  • The patient may be a candidate for a boost to the tumour bed.
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
Show all 14Show fewer
  • Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery.
  • Primary systemic therapy of an operable breast cancer is accepted.
  • If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted.
  • Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated
  • Postoperative infection and/or seroma giving indication for drainage during RT is accepted
  • Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
  • Signed informed consent
  • Affiliated to the Social Security system

Who cannot join

  • Previous breast cancer or DCIS of the breast.
  • Bilateral breast cancer
  • Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
  • The patient has an indication for boost to 1 or more regional nodes
  • Previous radiotherapy to the chest region
  • Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
  • Pregnant or lactating
  • Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • Clinique de l'Europe

    Amiens, 80090

  • Institut de Cancerologie de L'Ouest-Paul Papin

    Angers

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux

  • Centre Jean Perrin

    Clermont-Ferrand

  • Hoptal Henri Mondor

    Créteil

  • Centre Georges Francois Leclerc

    Dijon

  • Centre Guillaume Le Conquerant

    Le Havre

  • Centre de radiothérapie Hartmann

    Levallois-Perret, 92309

  • Centre Galilée - Hôpital Privé La Louvière

    Lille, 59800

  • Centre Oscar Lambret

    Lille

  • Clinique Chenieux

    Limoges, 87039

  • Hôpital du Scorff

    Lorient, 56100

  • Centre Leon Berard

    Lyon

  • Institut Paoli Calmettes

    Marseille, 13273

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Institut de Cancerologie de Lorraine

    Nancy

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Saint-Louis

    Paris

  • Institut Curie

    Paris

  • Centre Eugene Marquis

    Rennes

  • Centre Henri Becquerel

    Rouen

  • Institut Curie- Rene Huguenin

    Saint-Cloud

  • Institut de Cancerologie de L'Ouest-Rene Gauducheau

    Saint-Herblain

  • Centre Paul Strauss

    Strasbourg

  • Institut Claudius Regaud

    Toulouse

  • CHU Bretonneau

    Tours, 37044

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence

The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks.

Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women.

The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments

Being tested
HYPOFRACTIONATED, NORMOFRACTIONATED
Keywords
Breast Cancer pT1-3, pN0-N3, M0, Lymph Node Irradiation

What participants receive

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

  • HYPOFRACTIONATEDRadiation

    Also called Experimental Arm

    40 Gy/ 15 fractions / 3 weeks

  • NORMOFRACTIONATEDRadiation

    Also called Standard Arm

    50 Gy/ 25 fractions / 5 weeks

Study groups in NCT03127995
Study groupRoleWhat they receive
HYPOFRACTIONATEDExperimental40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: * sequential boost with 40 Gy to CTV breast in 15 fractions and 16 Gy to CTV boost in 8 fractions * or simultaneous integrated boost (SIB) with 42.3 Gy on CTV breast and 52.2 Gy on CTV boost in 18 fractions
Receives: Radiation: HYPOFRACTIONATED
NORMOFRACTIONATEDOther50 Gy / 25 fractions, 2.0 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: * sequential boost with 50 Gy to CTV breast in 25 fractions and 16 Gy to CTV boost in 8 fractions * or simultaneous integrated boost (SIB) with 51.52 Gy on CTV breast and 63 Gy on CTV boost in 28 fractions
Receives: Radiation: NORMOFRACTIONATED

What is being measured

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

  1. Arm Lymphedema

    Occurrence radiation-induced late morbidity measured as lymphedema of the arm on the treated side at 3 years after adjuvant radiotherapy as follows: At least≥ 10% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side relative to the baseline value, compared to the contralateral side circumference also relative to its baseline value.

    Measured: At 3 years

Secondary outcomes (11)

  1. Functional Assessment

    Flexion/abduction of the upper arm will be assessed.

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  2. Aesthetics Assessment-FIBROSIS

    Fibrosis as tissue induration, telangiectasia, oedema of the breast/chest wall and dyspigmentation will be evaluated according the LENT-SOMA scoring scale.

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  3. Aesthetics Assessment-BIS SCORE

    The patient evaluates satisfaction on The Body Image Score (BIS) where has been added an extra question regarding clothing habits and furthermore based on the study by Lyngholm et al also 2 more questions regarding the satisfaction with the appearance of the treated breast after breast conservation with and without comparison to the opposite breast as done in the DBCG HYPOII trial. In addition, it will ask if the patient treated with breast conservation has had lipo-feeling injection in the breast during follow up.

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  4. Aesthetics Assessment-Global Cosmestic

    The global cosmetic result after breast conservation will be based on Harris´ 4-point scale modified by Rune Gärtner et al

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  5. CTCAE Toxicity Assessment

    Acute/ late toxicity will be assessed according to the flowchart and performed based on CTCAE V4

    Measured: Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  6. RTOG/EORTC Toxicity Assessment

    Acute/ late toxicity will be assessed according to the flowchart and performed based on Toxicity Criteria of RTOG/EORTC

    Measured: Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  7. Cancer Related events

    Cancer related endpoints are secondary endpoints in this trial. It's a composite outcome taking into account all relapse events (locoregional, invasive disease, distant disease), breast-cancer specific survival, and causes of death as defined per DATECAN guidelines. All time to cancer related endpoints are defined as starting from the date of randomization until the event.

    Measured: 6 months after the last fraction received, every year during 5 years, 10 years

  8. Cost-Utility

    A cost-utility analysis comparing radiotherapy regimens will be performed based on QALYs

    Measured: Week 3 or week 7 of treatment according the treatment arm and boost realization

  9. Quality of Life QLQ-C30

    Patients' quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  10. Quality of Life EORTC BR23

    Patients' quality of life will be assessed using self-administered questionnaire EORTC BR23

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

  11. Quality of Life Euroqol EQ-5D5D

    Patients' quality of life will be assessed using self-administered questionnaire Euroqol EQ-5D5D

    Measured: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

Timeline

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

  1. First posted25 Apr 2017
  2. Study startSep 2016
  3. Primary completion31 Dec 2022
  4. Study completionSep 2030 (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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127995
Sponsor's protocol ID
UC-0107/1604
Other IDs
2016-A00702-49
Acronym
HYPOG-01
Status last verified
Apr 2024
First submitted
15 Dec 2016
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rivera S, Ghodssighassemabadi R, Auzac G, Brion T, Kirova Y, Racadot S, Benchalal M, Clavier JB, Charra Brunaud C, Groulier A, Argo-Leignel D, Peignaux K, Benyoucef A, Pasquier D, Guilbert P, Goineau A, Tallet A, Bergeaud M, Lamrani-Ghaouti A, Michiels S; HypoG-01 trialists. 5-year results of hypofractionated locoregional radiotherapy in early breast cancer HypoG-01 (UNICANCER): a French multicentre, randomised, non-inferiority, phase 3, open-label, controlled trial. Lancet. 2026 Mar 7;407(10532):976-987. doi: 10.1016/S0140-6736(25)02597-8.

    PubMed 41794436

Questions about this trial

What is this clinical trial studying?

A study testing HYPOFRACTIONATED and NORMOFRACTIONATED in people with Breast Cancer Female, run by UNICANCER at 28 sites in France.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm Lymphedema (time frame: At 3 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 NCT03127995, 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 9 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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