Breast CancerTOMOBREASTNCT02281149
Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:
An observational study of Breast Cancer, run by Centre Oscar Lambret at 2 sites in France.
Trial summary
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Nov 2014to 31 Mar 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: prospective study of routine care done on women with breast cancer treated by adjuvant radiotherapy with intensity modulated
Who may be able to join
- 1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient
Who cannot join
- - Metastatic disease
- - Patient having another severe disease or uncontrolled which could jeopardize the trial participation
- - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Léonard de Vinci
Douai, 59500
Centre Oscar Lambret
Lille, 59020
About this study
Official title: Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.
Read the detailed description
Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient.
The therapeutic support and monitoring are standard.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiotherapy, intensity modulation, toxicity
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and tardive toxicity according to NCI-CTCAE v4.0
according to NCI-CTCAE v4.0
Measured: up to 5 years
Secondary outcomes (4)
Quality of life according to QLQC-30
Quality of life according to QLQC-30
Measured: up to 24 months
Quality of life according to BR-23 module
Quality of life according to BR-23 module
Measured: up to 24 months
Disease free survival
according to RECIST 1.1
Measured: up to 5 years
esthetic results
by physician and patient according to a scale (good, excellent, moderate and poor)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study start18 Nov 2014
- Primary completion31 Dec 2022
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David PASQUIER, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281149
- Sponsor's protocol ID
- TOMOBREAST-1307
- Other IDs
- 2013-A01846-39
- Acronym
- TOMOBREAST
- Status last verified
- Sep 2026
- First submitted
- 28 Oct 2014
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pasquier D, Bataille B, Le Tinier F, Bennadji R, Langin H, Escande A, Tresch E, Darloy F, Carlier D, Crop F, Lartigau E. Correlation between toxicity and dosimetric parameters for adjuvant intensity modulated radiation therapy of breast cancer: a prospective study. Sci Rep. 2021 Feb 11;11(1):3626. doi: 10.1038/s41598-021-83159-3.
PubMed 33574446
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life
- ClinicalTrials.gov ID
- NCT02281149
- Acronym / sponsor ID
- TOMOBREAST / TOMOBREAST-1307
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiotherapy, intensity modulation, toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Nov 2014 (estimated)
- 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.
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.
Detailed description
Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient.
The therapeutic support and monitoring are standard.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prospective study of routine care done on women with breast cancer treated by adjuvant radiotherapy with intensity modulated
Key inclusion criteria (1 listed)
- 1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient
Key exclusion criteria (3 listed)
- - Metastatic disease
- - Patient having another severe disease or uncontrolled which could jeopardize the trial participation
- - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acute and tardive toxicity according to NCI-CTCAE v4.0
Time frame: up to 5 years
according to NCI-CTCAE v4.0
4 secondary outcomes
Quality of life according to QLQC-30
Time frame: up to 24 months
Quality of life according to BR-23 module
Time frame: up to 24 months
Disease free survival
Time frame: up to 5 years
esthetic results
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 33574446Pasquier D, Bataille B, Le Tinier F, Bennadji R, Langin H, Escande A, Tresch E, Darloy F, Carlier D, Crop F, Lartigau E. Correlation between toxicity and dosimetric parameters for adjuvant intensity modulated radiation therapy of breast cancer: a prospective study. Sci Rep. 2021 Feb 11;11(1):3626. doi: 10.1038/s41598-021-83159-3.
- 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. This study is not recruiting at the moment.
David PASQUIER, MD principal investigator
Centre Oscar Lambret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Oscar Lambret at 2 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
acute and tardive toxicity according to NCI-CTCAE v4.0 (time frame: up to 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 NCT02281149, 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 17 Sep 2026.