Neoplasms, BreastPhase 1NCT00058526
A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
A Phase 1 study testing Immunotherapeutic SB719125 (Primary) in people with Neoplasms, Breast, run by GlaxoSmithKline at 17 sites in 5 countries.
Trial summary
Treatment phase: The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- Immunotherapeutic SB719125 (Primary)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 20 Mar 2003to 6 Sep 2006
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a previous diagnosis of HER2/neu-positive breast cancer: FISH positive test (for HercepTest 2+ patients), or, HercepTest 3+ patients.
- Patients must be Stage II with at least one positive node or Stage III in remission. Patients must have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment.
- Patient must have completed at least one course of standard adjuvant treatment within 5 years of study entry.
- Patient may be on concurrent hormonal therapy.
- Patient must be free of recurrent breast cancer as shown by standard diagnostic tests at entry onto study.
- Patient must have a chest X-ray showing no evidence of disease.
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- Patient should have an expected survival of at least 12 months.
- Written informed consent must be obtained prior to any protocol-specific procedures being performed.
- Patient must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0.
- Patient must not be pregnant and must use adequate contraception throughout the study and must plan to not bear children in the future.
- Patient must not be lactating.
- Patient must have a negative pregnancy test prior to enrollment. Pregnancy testing need not be done for patients who are > 55 years of age, post-menopausal or surgically sterile.
- Patient must be 40 to 70 years of age inclusive. Patients younger than 40 years of age may be enrolled if they are sterile and incapable of childbearing. Chemotherapy-induced amenorrhea is not considered to be a sign of sterility.
- Patient must have adequate bone marrow reserve as indicated by: WBC ≥3000/mm3, neutrophils ≥1500/ mm3, platelets ≥100,000 mm3, lymphocytes ≥1000/mm3, and hemoglobin ≥10.0 g/dL.
- Patient must have an absolute CD4 cell count of >200 cells/mm3.
- Patient must have adequate renal function.
- Patient must have adequate hepatic function as indicated by: serum bilirubin within normal limits, aspartate aminotransferase <1.5 times the upper limit of normal and an alkaline phosphatase <1.2 times the upper limit of normal. Patients with an alkaline phosphatase above normal must have negative bone scans and abdominal CT scans prior to entry onto protocol.
- Patient must have a baseline left ventricular ejection fraction (LVEF) measured by multi-gated acquisition (MUGA) scan equal to or greater than the lower limit of normal for the radiology facility. The serial MUGA scans for each individual must also be performed at the same radiology facility, using the same equipment in the same manner, for consistency of method.
- Patients who had an earlier baseline MUGA scan at the radiological facility of the investigator's site to be used in the study, such as a MUGA scan done prior to adjuvant treatment, must meet the above criteria for LVEF AND must also not have had a decrease in LVEF of above 15 percentage points from the original baseline MUGA scan. Patients who have not had a MUGA scan done at this radiological facility prior to adjuvant treatment must have a normal MUGA scan at screening.
- Patient must not be known to be HIV positive. Results of virology screening must indicate that the patient has negative serology for HCV (hepatitis C virus) and is negative for HBsAg (hepatitis B surface antigen). (HBV testing indicating positive serology (antibodies) is allowed.)
Who cannot join
- Patients who are presently being treated with Herceptin or have been treated with Herceptin in the past.
- Patients who have received surgery or chemotherapy treatments within 8 weeks prior to enrollment. Patients who have received radiation therapy within 12 weeks prior to enrollment.
- Patients who have received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose).
- Patients with any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or prothrombotic disorder.
- Patients with auto-immune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease, Graves' disease and Hashimoto's disease.
- Patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
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- Patients with previous splenectomy or radiation to the spleen.
- Patients who have received a major organ graft (including bone-marrow transplantation).
- Patients who require chronic oral treatment (defined as more than 14 days) with immunosuppressive agents including glucocorticosteroids or other immune-modifying drugs.
- Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for > 2 years and highly likely to have been cured.
- Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- Patients with previous congestive heart failure or difficult-to-control hypertension. Patients with known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on electrocardiogram (EKG) or previous myocardial infarction.
- Patients with psychiatric or addictive disorders that may compromise the ability to give informed consent, or comply with the trial procedures.
- Patients who have received any investigational or non-registered drug or non-registered vaccine other than the study product within the 30 days preceding the first dose of study product, or who plan to receive such a drug during the study period.
- Patients who have received any immunoglobulins and/or blood products within the 3 weeks prior to study product administration.
- Patients who have received any commercial vaccine within one week before the first dose of the study product.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States4 sites
GSK Investigational Site
Boca Raton, Florida, 33428
GSK Investigational Site
Buffalo, New York, 14263
GSK Investigational Site
Charlotte, North Carolina, 28203
GSK Investigational Site
Seattle, Washington, 98195
Belgium4 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Charleroi, 6000
GSK Investigational Site
Leuven, 3000
Australia3 sites
GSK Investigational Site
East Melbourne, Victoria, 3002
GSK Investigational Site
Footscray, Victoria, 3011
GSK Investigational Site
Heidelberg, Victoria, 3084
France3 sites
GSK Investigational Site
Lyon, 69373
GSK Investigational Site
Paris, 75248
GSK Investigational Site
Saint-Herblain, 44805
Italy3 sites
GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Perugia, Umbria, 06156
GSK Investigational Site
Rome, Lazio, 00161
About this study
Official title: A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer
Treatment phase:
The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product.
Read more
Five-year follow-up phase:
This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.
- Conditions
- Neoplasms, Breast
- Being tested
- Immunotherapeutic SB719125 (Primary)
- Keywords
- dHER2-AS15 ASCI, Immunotherapeutic, Dose escalation, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapeutic SB719125 (Primary)Biological
Also called dHER2 ASCI
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Six doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. Receives: Biological: Immunotherapeutic SB719125 (Primary) |
| Cohort 2 | Experimental | Six doses of dHER2 (100 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. Receives: Biological: Immunotherapeutic SB719125 (Primary) |
| Cohort 3 | Experimental | Six doses of dHER2 (500 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively. Receives: Biological: Immunotherapeutic SB719125 (Primary) |
| Cohort 4 | Experimental | Three doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 4, and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively. Receives: Biological: Immunotherapeutic SB719125 (Primary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicity (DLT)
Measured: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of cardiotoxicity
Measured: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of Grade 3 or 4 adverse events
Measured: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of solicited local and general signs and symptoms recorded by the patient on diary cards
Measured: Period of eight days (Day 0 to Day 7) immediately after each administration of the study treatment
Occurrence of unsolicited non-serious adverse events
Measured: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of serious adverse events
Measured: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Hematological, biochemical (including auto-immunity) and urinalysis parameters
Measured: During the study period (until Week 40 or 43)
Changes in vital signs
Measured: During the entire study period (until Week 40 or 43)
Physical examination findings
Measured: During the study period (until Week 40 or 43)
Secondary outcomes (5)
Anti-dHER2, anti-HER2 ECD (extracellular domain), anti-HER2 ICD (intracellular domain) antibody concentrations
Measured: Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity
Measured: Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
In vitro functional activity response (e.g. growth inhibition of HER2-overexpressing breast tumor cells) expressed as a percentage of inhibition
Measured: After four or six administrations of the study treatment
Antibody-dependent cellular cytotoxicity (ADCC, % of lysis) - optionally
Measured: After four or six administrations of the study treatment
In vitro cellular immune response to dHER2, HER2 ECD and HER2 ICD as shown by lymphoproliferative response (expressed by stimulation index) and by secretion of interferon-γ and interleukin-5 expressed by concentration (pg/mL)
Measured: At baseline, after Dose 4, after Dose 6, at six months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study start20 Mar 2003
- Primary completion6 Sep 2006
- Study completion6 Sep 2006
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 Neoplasms, BreastStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058526
- Sponsor's protocol ID
- 719125/002
- Other IDs
- 104482
- Status last verified
- May 2017
- First submitted
- 7 Apr 2003
- Last updated
- 15 May 2017
- Results posted
- No
Publications
Limentani SA, Campone M, Dorval T, Curigliano G, de Boer R, Vogel C, White S, Bachelot T, Canon JL, Disis M, Awada A, Berliere M, Amant F, Levine E, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors. Breast Cancer Res Treat. 2016 Apr;156(2):319-30. doi: 10.1007/s10549-016-3751-x. Epub 2016 Mar 18.
PubMed 26993131
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer
- ClinicalTrials.gov ID
- NCT00058526
- Acronym / sponsor ID
- 719125/002
- Conditions
- Neoplasms, Breast
- Keywords
- dHER2-AS15 ASCI, Immunotherapeutic, Dose escalation, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2003 (actual)
- Primary completion
- 6 Sep 2006 (actual)
- Study completion
- 6 Sep 2006 (actual)
- First posted
- 9 Apr 2003 (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.
Treatment phase:
The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product.
Five-year follow-up phase:
This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Immunotherapeutic SB719125 (Primary)Six doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. |
| Cohort 2 | Experimental | Biological: Immunotherapeutic SB719125 (Primary)Six doses of dHER2 (100 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. |
| Cohort 3 | Experimental | Biological: Immunotherapeutic SB719125 (Primary)Six doses of dHER2 (500 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively. |
| Cohort 4 | Experimental | Biological: Immunotherapeutic SB719125 (Primary)Three doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 4, and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have a previous diagnosis of HER2/neu-positive breast cancer: FISH positive test (for HercepTest 2+ patients), or, HercepTest 3+ patients.
- Patients must be Stage II with at least one positive node or Stage III in remission. Patients must have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment.
- Patient must have completed at least one course of standard adjuvant treatment within 5 years of study entry.
- Patient may be on concurrent hormonal therapy.
- Patient must be free of recurrent breast cancer as shown by standard diagnostic tests at entry onto study.
Key exclusion criteria (16 listed)
- Patients who are presently being treated with Herceptin or have been treated with Herceptin in the past.
- Patients who have received surgery or chemotherapy treatments within 8 weeks prior to enrollment. Patients who have received radiation therapy within 12 weeks prior to enrollment.
- Patients who have received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose).
- Patients with any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or prothrombotic disorder.
- Patients with auto-immune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease, Graves' disease and Hashimoto's disease.
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 |
|---|---|---|
| Immunotherapeutic SB719125 (Primary)Also: dHER2 ASCIIntramuscular injection | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Occurrence of dose limiting toxicity (DLT)
Time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of cardiotoxicity
Time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of Grade 3 or 4 adverse events
Time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of solicited local and general signs and symptoms recorded by the patient on diary cards
Time frame: Period of eight days (Day 0 to Day 7) immediately after each administration of the study treatment
Occurrence of unsolicited non-serious adverse events
Time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of serious adverse events
Time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Hematological, biochemical (including auto-immunity) and urinalysis parameters
Time frame: During the study period (until Week 40 or 43)
Changes in vital signs
Time frame: During the entire study period (until Week 40 or 43)
Physical examination findings
Time frame: During the study period (until Week 40 or 43)
5 secondary outcomes
Anti-dHER2, anti-HER2 ECD (extracellular domain), anti-HER2 ICD (intracellular domain) antibody concentrations
Time frame: Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity
Time frame: Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
In vitro functional activity response (e.g. growth inhibition of HER2-overexpressing breast tumor cells) expressed as a percentage of inhibition
Time frame: After four or six administrations of the study treatment
Antibody-dependent cellular cytotoxicity (ADCC, % of lysis) - optionally
Time frame: After four or six administrations of the study treatment
In vitro cellular immune response to dHER2, HER2 ECD and HER2 ICD as shown by lymphoproliferative response (expressed by stimulation index) and by secretion of interferon-γ and interleukin-5 expressed by concentration (pg/mL)
Time frame: At baseline, after Dose 4, after Dose 6, at six months follow-up visit
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 15 May 2017.
- Derived from this study: PubMed 26993131Limentani SA, Campone M, Dorval T, Curigliano G, de Boer R, Vogel C, White S, Bachelot T, Canon JL, Disis M, Awada A, Berliere M, Amant F, Levine E, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors. Breast Cancer Res Treat. 2016 Apr;156(2):319-30. doi: 10.1007/s10549-016-3751-x. Epub 2016 Mar 18.
- Results for study 719125/002 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immunotherapeutic SB719125 (Primary) in people with Neoplasms, Breast, run by GlaxoSmithKline at 17 sites in 5 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 20 inclusion and 16 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Belgium, Australia, France, Italy. 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?
Occurrence of dose limiting toxicity (DLT) (time frame: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)). The study lists 9 primary outcomes in all. 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 NCT00058526, 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 15 May 2017.