Breast CancerPhase 2NCT00019812
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
A Phase 2 study testing trastuzumab and paclitaxel in people with Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab and paclitaxel
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 1999to Feb 2004
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic breast cancer with HER2 overexpression
- Radiographically or physically measurable disease that can be biopsied safely under local anesthesia
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- AST and ALT no greater than 5 times ULN
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 2 weeks since prior hormonal therapy
- No concurrent hormone receptor therapy (e.g., tamoxifen or armidex)
Radiotherapy:
- Localized palliative external beam radiotherapy allowed
Surgery:
- Not specified
Other:
- Concurrent bisphosphonates allowed
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Mary Babb Randolph Center
Morgantown, West Virginia, 26506-9162
About this study
Official title: Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.
Read the detailed description
OBJECTIVES:
- Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
- Provide access to trastuzumab and paclitaxel for these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, paclitaxel
- Keywords
- stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1999
- Study completionFeb 2004
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 2
- Primary purpose
- Treatment
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Susan E. Bates, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019812
- Sponsor's protocol ID
- 990121
- Other IDs
- 99-C-0121, NCI-T98-0087, CDR0000067227
- Status last verified
- Apr 2003
- First submitted
- 11 Jul 2001
- Last updated
- 23 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00019812
- Acronym / sponsor ID
- 990121
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Study completion
- Feb 2004 (actual)
- First posted
- 27 Jan 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.
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.
Detailed description
OBJECTIVES:
- Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
- Provide access to trastuzumab and paclitaxel for these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Biological | – |
| paclitaxel | 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 Mar 2012.
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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.
Susan E. Bates, MD principal investigator
National Cancer Institute (NCI)
3 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 trastuzumab and paclitaxel in people with Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 3 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?
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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Mar 2012.