Breast CancerPhase 2NCT00427427
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
A Phase 2 study testing Trastuzumab in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2007
- 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
- Confirmed non-metastatic infiltrating carcinoma of the breast.
- HER-2 amplified (FISH +) determination in 2004 or thereafter.
- ECOG performance status 0-2.
- Patients 18 years of age or older.
- HER-2 status is determined by FISH test.
- The following criteria are applicable to the trastuzumab treatment group:
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- Normal LVEF as determined by ECHO or MUGA. If baseline LVEF > 75%, then LVEF shall be repeated to determine if falsely elevated.
- Adequate bone marrow function as indicated by the following: ANC >1500/mL, Platelets >/=100,000/mL, Hemoglobin >9 g/dL
- Adequate renal function,as indicated by serum creatinine </= 1.5 x ULN
- Adequate liver function, as indicated by total bilirubin </= 1.5 x ULN
- AST and ALT < 2 x ULN unless related to primary disease.
- If female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
- Signed informed consent has been obtained.
Who cannot join
- Non-confirmed HER-2 positive by FISH infiltrating carcinoma of the breast.
- Evidence of metastatic disease.
- Previous trastuzumab treatment.
- Concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
- Patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
- Symptomatic intrinsic lung disease resulting in dyspnea at rest.
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- Concurrent life-limiting disease with a life expectancy of less than one year.
- Pregnancy, nursing women, and fertile women who do not practice birth control.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Revlon/UCLA Breast Center
Los Angeles, California, 90095
About this study
Official title: A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy.
Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible.
Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.
Read the detailed description
Study Phase- Phase II Study Type- Interventional Study Design-
This is an open label, non-randomized phase II study in patients with non-metastatic HER-2 positive breast cancer by FISH diagnosed in 2004 or thereafter. Potential patients will sign a written ICF prior to completing a questionnaire designed to determine what factors may affect a patient's acceptance of Herceptin® treatment. After answering the questionnaire, patients will be given the following options:
- to receive one year of trastuzumab treatment and annual follow-up for 5 years
- to decline trastuzumab treatment but serve as a comparison group member for monitoring safety and effectiveness of trastuzumab and to have annual follow-up for 5 years
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab
- Keywords
- non-metastatic breast cancer, HER-2 positive breast cancer, Herceptin (trastuzumab), delayed adjuvant therapy, acceptability rate, non-metastatic, HER-2 positive 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.
TrastuzumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
To evaluate signs and symptoms of cardiotoxicity.
Secondary outcomes (2)
Annual assessment of recurrent disease.
Overall survival and disease specific survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Study completionOct 2007
Why it stopped: lack of accrual
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 Jonsson Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Helena R Chang, M.D, Ph.D., Principal investigator, Revlon/UCLA Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427427
- Sponsor's protocol ID
- IRB# 06-05-104
- Other IDs
- H3754s
- Status last verified
- Oct 2007
- First submitted
- 25 Jan 2007
- Last updated
- 1 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00427427
- Acronym / sponsor ID
- IRB# 06-05-104
- Conditions
- Breast Cancer
- Keywords
- non-metastatic breast cancer, HER-2 positive breast cancer, Herceptin (trastuzumab), delayed adjuvant therapy, acceptability rate, non-metastatic, HER-2 positive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 29 Jan 2007 (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 the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy.
Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible.
Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.
Detailed description
Study Phase- Phase II Study Type- Interventional Study Design-
This is an open label, non-randomized phase II study in patients with non-metastatic HER-2 positive breast cancer by FISH diagnosed in 2004 or thereafter. Potential patients will sign a written ICF prior to completing a questionnaire designed to determine what factors may affect a patient's acceptance of Herceptin® treatment. After answering the questionnaire, patients will be given the following options:
- to receive one year of trastuzumab treatment and annual follow-up for 5 years
- to decline trastuzumab treatment but serve as a comparison group member for monitoring safety and effectiveness of trastuzumab and to have annual follow-up for 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Confirmed non-metastatic infiltrating carcinoma of the breast.
- HER-2 amplified (FISH +) determination in 2004 or thereafter.
- ECOG performance status 0-2.
- Patients 18 years of age or older.
- HER-2 status is determined by FISH test.
Key exclusion criteria (9 listed)
- Non-confirmed HER-2 positive by FISH infiltrating carcinoma of the breast.
- Evidence of metastatic disease.
- Previous trastuzumab treatment.
- Concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
- Patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
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 |
|---|---|---|
| Trastuzumab | Drug | – |
Primary outcome
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
To evaluate signs and symptoms of cardiotoxicity.
2 secondary outcomes
Annual assessment of recurrent disease.
Overall survival and disease specific survival.
Results and safety
The study was stopped early (reason given: lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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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.
Helena R Chang, M.D, Ph.D. principal investigator
Revlon/UCLA Breast Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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 13 inclusion and 9 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 1 Aug 2016. 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 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 was stopped early (reason given: lack of accrual). 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?
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.. The study lists 2 primary outcomes in all. 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 1 Aug 2016.