Breast CancerPhase 3TSARINENCT01613482
TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
A Phase 3 study testing cerebral prophylactic radiation, Trastuzumab and Other chemotherapy in association with Trastuzumab in people with Breast Cancer and Metastasis, run by Centre Oscar Lambret at 26 sites in France.
Trial summary
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Metastasis, Sur-expressing Her2-neu
- What is being tested?
- cerebral prophylactic radiation, Trastuzumab and Other chemotherapy in association with Trastuzumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 26 sitesFrance
- Study dates
- Jan 2008to Jan 2012
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
- Visceral metastasis, only or multiple
- First line metastasis treatment by Trastuzumab in association with chemotherapy
- Good general conditions: OMS=<2 or Karnofsky >=70%
- Age > 18 years and < 70 years
- Life expectancy >=3 mois
Show all 10Show fewer
- No Trastuzumab since more of 6 months
- No cerebral metastasis (MRI)
- Efficacy contraception for women with genital capacities
- Consent signed by the patient
Who cannot join
- Contraindication to IRM
- Psychiatric decease
- Prior cerebral radiotherapy,
- Geographical constraint, compromising the fallow of patients
- Infectious or other serious pathology, likely to stop the treatment
- Positive serology (HIV, hBC, hBS)
- Inclusion in an other clinical trial or in the 4 weeks before th inclusion
- Pregnant or breastfeeding women
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Centre Paul Papin
Angers, 49933
Centre Hospitalier
Boulogne-sur-Mer, 62200
Centre Maurice Tubiana
Caen, 14052
Centre G-François Baclesse
Caen, 14076
Centre Léonard de Vinci
Dechy, 59187
Centre Médical de Forcilles
Forcilles-attilly, 77150
Clinique des Ormeaux- Vauban
Le Havre, 76600
Centre Bourgogne
Lille, 59000
Centre Oscar LAMBRET
Lille, 59020
CHU Dupuytren
Limoges, 87042
Clinique Clinique Clementville
Montpellier, 34000
Centre Azuréen de Cancérologie
Mougins, 06250
Centre Hospitalier de Mulhouse
Mulhouse, 68100
Centre Catherine de Sienne
Nantes, 44202
Clinique Hartmann
Neuilly-sur-Seine, 92200
Centre Antoine Lacassagne
Nice, 06189
Centre médical Oncogard
Nîmes, 30907
Hôpital Tenon
Paris, 75020
Centre Catalan d'Oncologie
Perpignan, 66000
Centre Hospitalier LYON SUD
Pierre-Bénite, 69495
Centre René Huguenin
Saint-Cloud, 92210
Centre Etienne DOLET
Saint-Nazaire, 44600
Centre de Cancérologie Paris Nord
Sarcelles, 95200
Oncorad Garonne
Toulouse, 31400
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
- Conditions
- Breast Cancer, Metastasis, Sur-expressing Her2-neu
- Being tested
- cerebral prophylactic radiation, Trastuzumab, Other chemotherapy in association with Trastuzumab
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral prophylactic radiationRadiation
24Gy, 12 fractions of 2 Gy
TrastuzumabDrug
Also called Herceptin
Weekly, 2mg/kg of corporal weight
Other chemotherapy in association with TrastuzumabDrug
other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Without cerebral prophylactic radiation Receives: Drug: Trastuzumab; Drug: Other chemotherapy in association with Trastuzumab |
| Arm B | Experimental | With cerebral prophylactic radiation Receives: Radiation: cerebral prophylactic radiation; Drug: Trastuzumab; Drug: Other chemotherapy in association with Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
free of cerebral metastasis survival
Measured: 5 years
Secondary outcomes (5)
survival (overall and free visceral progression)
Measured: 5 years
evaluate neurological, haemorrhagic, skin toxicities
weekly during radiotherapy and 2 weeks after radiotherapy
Measured: During study
neurological toxicities
- neurological exams
- Cognitive test
- Subjective questionnaire of cognitive complaint
- questionnaire of EORTC QLQ-BN20
Measured: During study
P105 value
Blood sample
Measured: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
quality of life
Questionnaire QLQ-bn20
Measured: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionJan 2012
Why it stopped: Lack of enrollment
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.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yazid BELKACEMI, MD, Principal investigator, y-belkacemi@o-lambret.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613482
- Sponsor's protocol ID
- TSARINE-0602
- Other IDs
- 2006-003390-27
- Acronym
- TSARINE
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2012
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
- ClinicalTrials.gov ID
- NCT01613482
- Acronym / sponsor ID
- TSARINE / TSARINE-0602
- Conditions
- Breast Cancer, Metastasis, Sur-expressing Her2-neu
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Jun 2012 (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.
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Trastuzumab, Drug: Other chemotherapy in association with TrastuzumabWithout cerebral prophylactic radiation |
| Arm B | Experimental | Radiation: cerebral prophylactic radiation, Drug: Trastuzumab, Drug: Other chemotherapy in association with TrastuzumabWith cerebral prophylactic radiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
- Visceral metastasis, only or multiple
- First line metastasis treatment by Trastuzumab in association with chemotherapy
- Good general conditions: OMS=<2 or Karnofsky >=70%
- Age > 18 years and < 70 years
Key exclusion criteria (8 listed)
- Contraindication to IRM
- Psychiatric decease
- Prior cerebral radiotherapy,
- Geographical constraint, compromising the fallow of patients
- Infectious or other serious pathology, likely to stop the treatment
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 |
|---|---|---|
| cerebral prophylactic radiation24Gy, 12 fractions of 2 Gy | Radiation | Arm B |
| TrastuzumabAlso: HerceptinWeekly, 2mg/kg of corporal weight | Drug | Arm A, Arm B |
| Other chemotherapy in association with Trastuzumabother chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session | Drug | Arm A, Arm B |
Primary outcome
free of cerebral metastasis survival
Time frame: 5 years
5 secondary outcomes
survival (overall and free visceral progression)
Time frame: 5 years
evaluate neurological, haemorrhagic, skin toxicities
Time frame: During study
neurological toxicities
Time frame: During study
P105 value
Time frame: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
quality of life
Time frame: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
Yazid BELKACEMI, MD principal investigator
y-belkacemi@o-lambret.fr
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cerebral prophylactic radiation, Trastuzumab and Other chemotherapy in association with Trastuzumab in people with Breast Cancer and Metastasis, run by Centre Oscar Lambret at 26 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 10 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: stopped early, 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 26 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.
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?
The study was stopped early (reason given: Lack of enrollment). 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?
free of cerebral metastasis survival (time frame: 5 years). 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 17 Sep 2026.