HER2-positive Breast CancerPhase 1BIRTHNCT02135159
Patients With Brain Metastases From HER2-positive Breast Cancer
A Phase 1 study testing TDM1 and Brain Sequential RT in people with HER2-positive Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- TDM1 and Brain Sequential RT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Mar 2017
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer with stage IV disease.
- HER-2 positive primary tumor, defined as: IHC3+, or IHC2+ and ISH positive.
- Non operable brain metastases (n ≥ 2) with at least one measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI.
- No stereotaxie radiotherapy indication
- At least two weeks from any specific breast cancer treatment (such as Trastuzumab, chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and radiotherapy).
- Adequate hematologic function (ANC ≥1x109/L, platelets ≥100 000/L; Hb >10g/dL), renal function (creatinine ≤ 1.5x UNL) and hepatic function (albumin ≥2.5 g/dL; serum bilirubin ≤1.5x ULN unless due to Gilbert's syndrome; AST and ALT ≤ 5x ULN if documented liver metastasis or ≤ 3x ULN without liver metastasis).
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- At least 18 years old.
- ECOG Performance Status of 0 to 2.
- Life expectancy ≥ 3 months.
- Potentially reproductive patients must agree to use an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the first study treatment.
- Patients must be affiliated to a Social Security System.
- Patient information and written informed consent form signed.
Who cannot join
- Previous whole brain radiotherapy (WBRT) or brain stereotaxie radiotherapy.
- Planned or concurrent systemic treatment or radiation therapy (other than corticosteroid, bisphosphonates or mannitol).
- Known contra-indication to MRI.
- Active concurrent malignancy. If there is a history of prior malignancy, the patient must be disease free for at least 10 years.
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as :
- infection,
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- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF ≤ 50%,
- current active hepatic or renal disease
- Pregnant women, women who are likely to become pregnant or are breast-feeding.
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Known hypersensibility to any component of T-DM1
- Patients who received any other investigational drugs within the 30 days prior to the screening visit.
- Individual deprived of liberty or placed under the authority of a tutor.
- Leptomeningeal metastases diagnosed by MRI
- Inclusion in another protocol within 30 days
- Brain metastases with severe intracranial hypertension clinical signs
- Other cancer except the known primary tumor or in situ cervix cancer or basocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Feasibility of Different Sequences of Combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy in Patients With Brain Metastases From HER2-positive Breast Cancer
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Read the detailed description
Determine the best sequences.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- TDM1, Brain Sequential RT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDM1Drug
Also called no other names
administration of the TDM1 by IV perfusion
Brain Sequential RTRadiation
Also called No other names
local RT
| Study group | Role | What they receive |
|---|---|---|
| TDM1 concommitant with RT | Experimental | T-DM1 (First injection day 1) followed by brain sequential RT (start day D3), second injection T-DM1 day 22. Receives: Drug: TDM1; Radiation: Brain Sequential RT |
| TDM1 during and after RT | Experimental | Brain sequential RT (start day 1) followed by T-DM1 (First injection day 15), second injection T-DM1 day 36. Receives: Drug: TDM1; Radiation: Brain Sequential RT |
| RT before TDM1 | Experimental | Brain sequential RT (start day 1) followed by T-DM1 (First injection day 22), second injection T-DM1 day 43. Receives: Drug: TDM1; Radiation: Brain Sequential RT |
| TDM1 before RT | Experimental | T-DM1 (First injection day 1) followed by brain sequential and concomitant RT (start day D18), second injection T-DM1 day 22. Receives: Drug: TDM1; Radiation: Brain Sequential RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal sequences of combined treatment
To determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Measured: 3 months
Secondary outcomes (1)
objective response
Objective responses (complete and partial response) by MRI according to the RECIST criteria (v1.1) and volumetric assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David AZRIA, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135159
- Sponsor's protocol ID
- VA2012/38
- Acronym
- BIRTH
- Status last verified
- Aug 2017
- First submitted
- 6 Feb 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Feasibility of Different Sequences of Combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy in Patients With Brain Metastases From HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02135159
- Acronym / sponsor ID
- BIRTH / VA2012/38
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 May 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.
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Detailed description
Determine the best sequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TDM1 concommitant with RT | Experimental | Drug: TDM1, Radiation: Brain Sequential RTT-DM1 (First injection day 1) followed by brain sequential RT (start day D3), second injection T-DM1 day 22. |
| TDM1 during and after RT | Experimental | Drug: TDM1, Radiation: Brain Sequential RTBrain sequential RT (start day 1) followed by T-DM1 (First injection day 15), second injection T-DM1 day 36. |
| RT before TDM1 | Experimental | Drug: TDM1, Radiation: Brain Sequential RTBrain sequential RT (start day 1) followed by T-DM1 (First injection day 22), second injection T-DM1 day 43. |
| TDM1 before RT | Experimental | Drug: TDM1, Radiation: Brain Sequential RTT-DM1 (First injection day 1) followed by brain sequential and concomitant RT (start day D18), second injection T-DM1 day 22. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed invasive breast cancer with stage IV disease.
- HER-2 positive primary tumor, defined as: IHC3+, or IHC2+ and ISH positive.
- Non operable brain metastases (n ≥ 2) with at least one measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI.
- No stereotaxie radiotherapy indication
- At least two weeks from any specific breast cancer treatment (such as Trastuzumab, chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and radiotherapy).
Key exclusion criteria (17 listed)
- Previous whole brain radiotherapy (WBRT) or brain stereotaxie radiotherapy.
- Planned or concurrent systemic treatment or radiation therapy (other than corticosteroid, bisphosphonates or mannitol).
- Known contra-indication to MRI.
- Active concurrent malignancy. If there is a history of prior malignancy, the patient must be disease free for at least 10 years.
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as :
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 |
|---|---|---|
| TDM1Also: no other namesadministration of the TDM1 by IV perfusion | Drug | RT before TDM1, TDM1 before RT, TDM1 concommitant with RT, TDM1 during and after RT |
| Brain Sequential RTAlso: No other nameslocal RT | Radiation | RT before TDM1, TDM1 before RT, TDM1 concommitant with RT, TDM1 during and after RT |
Primary outcome
optimal sequences of combined treatment
Time frame: 3 months
To determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
1 secondary outcome
objective response
Time frame: 1 year
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 14 Aug 2017.
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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 AZRIA principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TDM1 and Brain Sequential RT in people with HER2-positive Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site 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 13 inclusion and 17 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 14 Aug 2017. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
optimal sequences of combined treatment (time frame: 3 months). 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 14 Aug 2017.