Stage II Breast CancerPhase 2NCT00080613
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
A Phase 2 study testing exemestane, adjuvant therapy and aromatase inhibition in people with Stage II Breast Cancer and Stage IIIA Breast Cancer, run by Robert H. Lurie Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- What is being tested?
- exemestane, adjuvant therapy and aromatase inhibition
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer
- Locally advanced disease (stage II or III)
- Not amenable to breast-conserving therapy at the time of diagnosis
- Measurable disease meeting 1 of the following criteria:
- Bidimensionally measurable palpable lesion at least 1 cm by caliper
- Unidimensionally measurable lesion at least 1 cm by a positive mammogram, ultrasound, or MRI
- No evidence of disease outside the breast or chest wall except ipsilateral axillary lymph nodes
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
- Postmenopausal, defined as any of the following:
- Over 60 years of age
- Over 45 years of age with an intact uterus and amenorrhea for more than 12 months
- Prior hysterectomy with follicle-stimulating hormone levels within the postmenopausal range
- Prior ovarian ablation (i.e., bilateral surgical)
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 1.5 times upper limit of normal (ULN)
Renal
- Creatinine less than 2 mg/dL
Other
- No other prior or concurrent cancer except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for breast cancer
Chemotherapy
- No prior chemotherapy for breast cancer
Endocrine therapy
- No prior hormonal therapy for breast cancer
Radiotherapy
- No prior radiotherapy for breast cancer
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen and/or progesterone receptor-positive breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane.
Secondary
- Determine the response rate by mammography, ultrasound, MRI, and positron emission tomography scan in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Compare the expression of hormone receptors and epidermal growth factor receptors (including HER2/neu) in patients prior to and after treatment with this drug and correlate these results with clinical response rates.
OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then continue exemestane once daily for a total of 5 years (including the 16 weeks before surgery).
Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
- Conditions
- Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- exemestane, adjuvant therapy, aromatase inhibition, conventional surgery, endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exemestaneDrug
adjuvant therapyProcedure or surgery
aromatase inhibitionProcedure or surgery
conventional surgeryProcedure or surgery
endocrine therapyProcedure or surgery
hormone therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II 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
Sponsor and investigators
- Lead sponsor
- Robert H. Lurie Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William John Gradishar, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080613
- Sponsor's protocol ID
- NU-02B4
- Other IDs
- CDR0000346457
- Status last verified
- Dec 2006
- First submitted
- 7 Apr 2004
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00080613
- Acronym / sponsor ID
- NU-02B4
- Conditions
- Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Lead sponsor
- Robert H. Lurie Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 8 Apr 2004 (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: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen and/or progesterone receptor-positive breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane.
Secondary
- Determine the response rate by mammography, ultrasound, MRI, and positron emission tomography scan in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Compare the expression of hormone receptors and epidermal growth factor receptors (including HER2/neu) in patients prior to and after treatment with this drug and correlate these results with clinical response rates.
OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then continue exemestane once daily for a total of 5 years (including the 16 weeks before surgery).
Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| exemestane | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| aromatase inhibition | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| endocrine therapy | Procedure or surgery | – |
| hormone therapy | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
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 10 Jul 2013.
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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.
William John Gradishar, MD principal investigator
Robert H. Lurie Cancer 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 exemestane, adjuvant therapy and aromatase inhibition in people with Stage II Breast Cancer and Stage IIIA Breast Cancer, run by Robert H. Lurie Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2013. 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 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 10 Jul 2013.