Breast CancerPhase 3NCT00212121
Radiation Dose Intensity Study in Breast Cancer in Young Women
A Phase 3 study testing high dose boost and boost in people with Breast Cancer, run by The Netherlands Cancer Institute at 18 sites in 2 countries.
Trial summary
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- high dose boost and boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2004to Dec 2025
- Phase
- Phase 3
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 50 years or younger.
- Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
- Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
- Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
- any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
- Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
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- Breast cancer stage: pT1-2pN0-2a M0.
- No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
- In cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
- In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
- In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
- No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- ECOG performance scale 2 or less.
Who cannot join
- Residual microcalcifications on mammogram.
- All histological types of malignancies other than invasive adenocarcinoma.
- In situ carcinoma of the breast, without invasive tumor.
- Concurrent pregnancy.
- Multicentric tumors, and multifocal. tumors excised using multiple excisions * Invasive breast cancer in both breasts.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
Hôpital J-Minjoz
Besançon, 25030
Institut Bergonié
Bordeaux, 33076
CHU Henri Mondor
Créteil, 94000
Centre Oscar Lambret
Lille, 59000
Institut Paoli Calmettes
Marseille, 13009
Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
Hôpital Saint Louis
Paris, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Eugène Marquis
Rennes, 35000
Centre Henri Becquerel
Rouen, 76000
Centre René Huguenin
Saint-Cloud, 92210
Centre René Gauducheau
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67085
CHU de Tours
Tours, 37000
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
Read the detailed description
Title of the study:
Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.
Background and aim of the study:
Several studies showed that breast conserving therapy (BCT) yields similar survival rates as mastectomy. BCT consists of lumpectomy followed by whole breast radiotherapy (WBRT). Three studies showed that an additional dose to the tumor bed, after 50 Gy WBRT, reduces the local recurrence rate (LRR). The largest of these 3 studies was a recent EORTC trial, which also showed that young age was an independent risk factor for LR after BCT.
In patients < 51 years of age, the LR rate was reduced with 50% after a 66 Gy dose to the tumor bed, compared to 50 Gy (5-year LRR 12% vs 5.9%, p < 0.02). However, the LRR in young women was still quite high (> 1% per year). Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed (26 Gy) reduces the LRR further. Therefore, we will compare the effect of a low boost dose (16 Gy) with the effect of a high boost dose (26 Gy) on the LRR, but also on the cosmetic outcome.
The second, very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR, lymph node metastases, distant metastases, survival, radiosensitivity, and age. For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible.
Population, study design, intervention:
Patients younger than 51 years of age, with stage T1-2N01-2aM0 breast cancer, and where the tumor can be locally excised with acceptable cosmetic result, will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed, after 50 Gy WBRT. Patients will be stratified based on age, tumor size, lymph node metastases, estrogen receptor status, interstitial or external boost irradiation, and institution. In principle frozen tumor samples and blood samples will be stored of each patient.
Endpoints and statistics:
The primary endpoint is LRR are 10 years. The secondary endpoint is cosmetic result, which will be quantified using digitized color photographs. In addition, patients will be asked to give their opinion about the cosmetic result using standardized questionnaires.
To find an increase in the local control rate of 88% to 93% at 10 year, with a power of 80% and a significance level of 5%, 580 patients will be included in each treatment arm.
Side studies:
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples. These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles, which may take more or less advantage of the additional radiation treatment.
- Conditions
- Breast Cancer
- Being tested
- high dose boost, boost
- Keywords
- breast cancer, radiotherapy, microarrays
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose boostRadiation
high dose boost
boostProcedure or surgery
low dose versus high dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | low dose boost (16 Gy) Receives: Radiation: high dose boost; Procedure: boost |
| 2 | Experimental | high boost (26 Gy) Receives: Radiation: high dose boost; Procedure: boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control at 10 yr
Measured: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
Secondary outcomes (1)
Cosmetic outcome
Measured: prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UNICANCER
- Responsible party
- Sponsor
- Investigators
- Liesbeth Boersma, MD, Study chair, MAASTRO Clinic, Heerlen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212121
- Sponsor's protocol ID
- M03RBC-young boost
- Other IDs
- 2003-13
- Status last verified
- Jan 2022
- First submitted
- 13 Sep 2005
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
- ClinicalTrials.gov ID
- NCT00212121
- Acronym / sponsor ID
- M03RBC-young boost
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiotherapy, microarrays
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- UNICANCER
- Study start
- Jul 2004
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Sep 2005 (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.
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
Detailed description
Title of the study:
Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.
Background and aim of the study:
Several studies showed that breast conserving therapy (BCT) yields similar survival rates as mastectomy. BCT consists of lumpectomy followed by whole breast radiotherapy (WBRT). Three studies showed that an additional dose to the tumor bed, after 50 Gy WBRT, reduces the local recurrence rate (LRR). The largest of these 3 studies was a recent EORTC trial, which also showed that young age was an independent risk factor for LR after BCT.
In patients < 51 years of age, the LR rate was reduced with 50% after a 66 Gy dose to the tumor bed, compared to 50 Gy (5-year LRR 12% vs 5.9%, p < 0.02). However, the LRR in young women was still quite high (> 1% per year). Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed (26 Gy) reduces the LRR further. Therefore, we will compare the effect of a low boost dose (16 Gy) with the effect of a high boost dose (26 Gy) on the LRR, but also on the cosmetic outcome.
The second, very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR, lymph node metastases, distant metastases, survival, radiosensitivity, and age. For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible.
Population, study design, intervention:
Patients younger than 51 years of age, with stage T1-2N01-2aM0 breast cancer, and where the tumor can be locally excised with acceptable cosmetic result, will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed, after 50 Gy WBRT. Patients will be stratified based on age, tumor size, lymph node metastases, estrogen receptor status, interstitial or external boost irradiation, and institution. In principle frozen tumor samples and blood samples will be stored of each patient.
Endpoints and statistics:
The primary endpoint is LRR are 10 years. The secondary endpoint is cosmetic result, which will be quantified using digitized color photographs. In addition, patients will be asked to give their opinion about the cosmetic result using standardized questionnaires.
To find an increase in the local control rate of 88% to 93% at 10 year, with a power of 80% and a significance level of 5%, 580 patients will be included in each treatment arm.
Side studies:
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples. These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles, which may take more or less advantage of the additional radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: high dose boost, Procedure: boostlow dose boost (16 Gy) |
| 2 | Experimental | Radiation: high dose boost, Procedure: boosthigh boost (26 Gy) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 50 years or younger.
- Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
- Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
- Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
- any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
Key exclusion criteria (5 listed)
- Residual microcalcifications on mammogram.
- All histological types of malignancies other than invasive adenocarcinoma.
- In situ carcinoma of the breast, without invasive tumor.
- Concurrent pregnancy.
- Multicentric tumors, and multifocal. tumors excised using multiple excisions * Invasive breast cancer in both breasts.
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 |
|---|---|---|
| high dose boosthigh dose boost | Radiation | 1, 2 |
| boostlow dose versus high dose | Procedure or surgery | 1, 2 |
Primary outcome
Local control at 10 yr
Time frame: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
1 secondary outcome
Cosmetic outcome
Time frame: prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Liesbeth Boersma, MD study chair
MAASTRO Clinic, Heerlen
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing high dose boost and boost in people with Breast Cancer, run by The Netherlands Cancer Institute at 18 sites in 2 countries.
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 13 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Netherlands. 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?
Results are not available in the source record.
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?
Local control at 10 yr (time frame: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.