Breast NeoplasmsPhase 2NCT00046371
Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients
A Phase 2 study testing THERATOPE® vaccine in people with Breast Neoplasms, run by Oncothyreon Canada Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- THERATOPE® vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 17 sitesUnited States
- Study dates
- Aug 2002to Aug 2005
- Phase
- Phase 2
- 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
Who may be able to join
- Histopathologically confirmed breast cancer
- Documented Stage IV disease
- Estrogen and/or progesterone-receptor positive
- Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks prior to enrolment
- Performance status, ECOG = 0 or 1
- Life expectancy > 12 weeks
- History of freedom from progression for at least 6 months following surgery with a curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment
- No radiotherapy or major surgery within 4 weeks prior to enrolment
Who cannot join
- Pregnant or lactating
- Known brain metastasis
- Bone marrow involvement as the only site of metastasis
- First line chemotherapy for Stage IV disease
- Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease
- Autoimmune disease, e. g., type I juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, Grave's disease, lupus, Crohn's disease, IBD, Hashimoto's thyroiditis
Show all 18Show fewer
- Known intercurrent infections (including HBV or HCV) or immunosuppression [human immunodeficiency virus (HIV) or other conditions] or clinical evidence of these conditions
- Other significant active infection
- Pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently
- Splenectomy
- Concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study
- Treatment with interferons (IFNs), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment
- Receipt of another investigational drug within 30 days of enrolment
- Known allergy to shellfish
- Known allergy to soy beans or soy products
- Known hypersensitivity to polysorbate 80
- Known hypersensitivity to the study drugs
- Legal incapacity or limited legal capacity
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Berkeley, California
Study site
Billings, Montana
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Des Moines, Iowa
Study site
Gastonia, North Carolina
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Morristown, New Jersey
Study site
Norfolk, Virginia
Study site
Plantation, Florida
Study site
Port Saint Lucie, Florida
Study site
Richmond, Virginia
Study site
San Francisco, California
Study site
Santa Monica, California
About this study
Official title: Open-Label, Phase II Trial of Immunological Response Rate, Safety, and Tolerability of THERATOPE® Vaccine in Subjects With Metastatic Breast Cancer Undergoing Treatment With Aromatase Inhibitors or Faslodex®
The purpose of this study is to examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy.
Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be eligible to be enrolled.
Read more
Patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study.
Information about the safety and tolerability of administration of the THERATOPE® vaccine will also be gathered during the course of the study.
- Conditions
- Breast Neoplasms
- Being tested
- THERATOPE® vaccine
- Keywords
- Cancer Vaccines, Aromatase, Receptors, Estrogen, Receptors, Progesterone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERATOPE® vaccineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2002 (estimated)
- Study startAug 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Oncothyreon Canada Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046371
- Sponsor's protocol ID
- STn-BR-105
- Status last verified
- Jan 2008
- First submitted
- 27 Sep 2002
- Last updated
- 23 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase II Trial of Immunological Response Rate, Safety, and Tolerability of THERATOPE® Vaccine in Subjects With Metastatic Breast Cancer Undergoing Treatment With Aromatase Inhibitors or Faslodex®
- ClinicalTrials.gov ID
- NCT00046371
- Acronym / sponsor ID
- STn-BR-105
- Conditions
- Breast Neoplasms
- Keywords
- Cancer Vaccines, Aromatase, Receptors, Estrogen, Receptors, Progesterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Oncothyreon Canada Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Oct 2002 (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 examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy.
Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be eligible to be enrolled.
Patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study.
Information about the safety and tolerability of administration of the THERATOPE® vaccine will also be gathered during the course of the study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathologically confirmed breast cancer
- Documented Stage IV disease
- Estrogen and/or progesterone-receptor positive
- Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks prior to enrolment
- Performance status, ECOG = 0 or 1
Key exclusion criteria (18 listed)
- Pregnant or lactating
- Known brain metastasis
- Bone marrow involvement as the only site of metastasis
- First line chemotherapy for Stage IV disease
- Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of 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 |
|---|---|---|
| THERATOPE® vaccine | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Jan 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THERATOPE® vaccine in people with Breast Neoplasms, run by Oncothyreon Canada Inc. at 17 sites in United States.
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 8 inclusion and 18 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 23 Jan 2008. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 23 Jan 2008.