Breast CancerPhase 2NCT00057993
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
A Phase 2 study testing trastuzumab and exemestane in people with Breast Cancer, run by Northwestern University.
Trial summary
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. 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 and exemestane
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage IV or locally advanced disease
- Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks
- HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry
- Measurable disease defined by 1 of the following criteria:
- At least 1 dimension at least 1 cm by CT scan or other imaging scan
- At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions)
- Palpable lesion with both diameters at least 1 cm with caliper OR
- Evaluable disease defined by 1 of the following criteria:
- Positive bone scan
- Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm
- Bone scan and CA 27.29 if bone scan only evaluable disease
- Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Postmenopausal by 1 of the following criteria:
- 60 years of age and over
- 45 years of age and over with amenorrhea more than 12 months and an intact uterus
- Follicle-stimulating hormone levels within postmenopausal range
- Undergone bilateral oophorectomy
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 1.5 times upper limit of normal
Renal
- Creatinine less than 2 mg/dL
Cardiovascular
- Ejection fraction greater than 50%
Other
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior trastuzumab (Herceptin)
Chemotherapy
- Prior chemotherapy allowed
Endocrine therapy
- No prior exemestane
- No other prior hormonal agent (except tamoxifen)
Radiotherapy
- Not specified
Surgery
- Not specified
About this study
Official title: Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of exemestane and trastuzumab (Herceptin), in terms of response rate and time to progression, in postmenopausal women with metastatic or locally advanced hormone-responsive, HER2/neu positive breast cancer.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1 and oral exemestane once daily. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, exemestane
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
trastuzumabBiological
exemestaneDrug
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 startJul 2002
- Primary completionAug 2004
- Study completionAug 2004
Why it stopped: Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.
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 Northwestern UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Virginia G. Kaklamani, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057993
- Sponsor's protocol ID
- NU 01B4
- Other IDs
- NU-01B4, PHARMACIA-NU-01B4
- Status last verified
- Jun 2012
- First submitted
- 7 Apr 2003
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00057993
- Acronym / sponsor ID
- NU 01B4
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Aug 2004
- Study completion
- Aug 2004
- 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.
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of exemestane and trastuzumab (Herceptin), in terms of response rate and time to progression, in postmenopausal women with metastatic or locally advanced hormone-responsive, HER2/neu positive breast cancer.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1 and oral exemestane once daily. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 | – |
| exemestane | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
Virginia G. Kaklamani, MD principal investigator
Robert H. Lurie Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab and exemestane in people with Breast Cancer, run by Northwestern University.
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: withdrawn, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 11 Jun 2012.