Breast CancerPhase 3LEANEXNCT00902954
Study of Exemestane After Anastrozole or Letrozole Treatment of Postmenopausal Women With Hormone Responsive Breast Cancer
A Phase 3 study testing anastrozole, letrozole and exemestane in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to compare the rate of disease free survival (DFS) and distant disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and anastrozole/letrozole 2-3 years switching to… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole, letrozole and exemestane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Jun 2011
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of written informed consent.
- Patient muse be female.
- Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
- A total mastectomy with institutional standard axillary nodal dissection.
- Lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation.
- Treatment of the breast cancer following diagnosis may have included any of the following; post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab.
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- The tumor must have been pathologic primary invasive carcinoma by core needle or open biopsy.
- The beginning of endocrine therapy (letrozole or anastrozole) must be no more than 6 weeks from the end day of chemotherapy or radiotherapy.
- The date of randomization must be no less than 2 years of letrozole and no more than 3 years letrozole treatment.
- Positive node is defined as defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Criteria Edition 6.
- Patients who have had neoadjuvant chemotherapy are eligible. Positive lymph node involvement can be defined either prior of neoadjuvant chemotherapy or at the time of surgery following their neoadjuvant therapy. Lymph node positivity would be defined as the following:
- Pre-neoadjuvant chemotherapy lymph node assessment must include identification of a histological positive axillary, internal mammary or supraclavicular determined by one of the following: FNA of lymph node or sentinel lymph node evaluation, or complete or limited axillary dissection.
- For patients that have completed their neoadjuvant chemotherapy, without prior documentation of a positive lymph node, lymph node positivity must be demonstrated at the time of their primary surgery as defined by either:
- Either sentinel lymph node or primary axillary dissection identifying a positive lymph node is acceptable as per standard institutional practice guidelines.
- Histological evidence of a N1-N3c lymph node involvement identified at the time of primary breast surgery following neoadjuvant chemotherapy.
- Presence of occult axillary lymph node with no evidence of primary breast tumor must be confirmed pathologically primary breast invasive carcinoma or DCIS with microinvasive. And the measurement of ER, PR and HER2 must be performed on the initial lymph nodes or breast tumors.
- Bilateral, synchronous breast cancer is allowed provided at least one of the primary tumors meets the eligibility criteria.
- Hormone receptor-positive tumors, defined as any detectable estrogen or progesterone receptor expression by institutional standards.Patients who are PR positive and ER negative are eligible for the trial. Tumor slides should be submitted for central evaluation of hormone receptor status as per Section.
- HER2 status must be known, Tumor slides should be submitted for central evaluation of hormone receptor status as per Section.
- Physical and laboratory examination as per standard institutional practice,should be obtained at the time of definitive surgery to demonstrate there is no evidence of metastatic or recurrent disease.
- Patients must be postmenopausal at the time of initial diagnosis. For study purposes, postmenopausal is defined as:
- Prior bilateral oophorectomy.
- Age ≥ 60 y.
- Age < 60 amenorrheic for 12 or more months and has postmenopausal levels of FSH and LH per local institutional standards
- If received adjuvant chemotherapy or tamoxifen and age < 60 y, the levels of FSH and LH must reached postmenopausal levels.
- If received adjuvant chemotherapy or LHRH antagonist and amenorrheic, the levels of FSH and LH must reached postmenopausal levels and be confirmed at least twice.
- Patients must have an WHO performance status of o or all per-disease performance without restriction, 1=restricted in physically strenuous activity but ambulatory.
- WBC > 3.0*10^9/L and platelets > 100*10^9/L.
- AST/SGOT or ALT/SGPT < 3 times ULN.
- Cr ≤ 2 times ULN. 19 Can swallow pills.
Who cannot join
- Presence of metastatic disease.
- Previous diagnosis of metachronous bilateral breast cancer.
- Previous or concomitant other (non-breast cancer) malignance within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell.
- Presence of other non-malignant disease which may prevent prolonged follow-up.
- Received neoadjuvant endocrine therapy.
- Adjuvant SERMs therapy (Tamoxifen or Toremifene) for more than 6 months before randomization.
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- Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
- Severe hepatic dysfunction defined as Child-Pugh grade C.
- Severe cardiac dysfunction defined above NYHA grade III.
- Presence of occult axillary lymph node with no evidence of primary breast tumor pathologically or DCIS with microinvasive. And the measurement of ER, PR and HER2 are not obtained.
- Uncontrolled psychological diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinsong Lu
Shanghai, Shanghai Municipality
Jinsong Lu, PhD, M.D, 862164175590 ext. 8700
About this study
Official title: A Randomized Trial, Phase IIIb, Open Label Study of Exemestane After Two to Three Years of Anastrozole/Letrozole Treatment of Postmenopausal Women With Hormone Receptor Positive Breast Cancer
The purpose of this study is to compare the rate of disease free survival (DFS) and distant disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, letrozole, exemestane
- Keywords
- Disease free survival, Distant disease free survival, Toxicity, Overall survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
anastrozole 1 mg qd
letrozoleDrug
letrozole 2.5 mg qd
exemestaneDrug
exemestane 25 mg qd
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | anastrozole/letrozole 2-3 years switching to exemestane 3-2 years Receives: Drug: anastrozole; Drug: letrozole; Drug: exemestane |
| B | Active comparator | anastrozole/letrozole 5 years Receives: Drug: anastrozole; Drug: letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: at 6, 12, 24, 36 months, then once every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2011 (estimated)
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 Fudan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Zhimin Shao, PhD, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902954
- Sponsor's protocol ID
- SHBCC0701
- Acronym
- LEANEX
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial, Phase IIIb, Open Label Study of Exemestane After Two to Three Years of Anastrozole/Letrozole Treatment of Postmenopausal Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00902954
- Acronym / sponsor ID
- LEANEX / SHBCC0701
- Conditions
- Breast Cancer
- Keywords
- Disease free survival, Distant disease free survival, Toxicity, Overall survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 15 May 2009 (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 compare the rate of disease free survival (DFS) and distant disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: anastrozole, Drug: letrozole, Drug: exemestaneanastrozole/letrozole 2-3 years switching to exemestane 3-2 years |
| B | Active comparator | Drug: anastrozole, Drug: letrozoleanastrozole/letrozole 5 years |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (30 listed)
- Provision of written informed consent.
- Patient muse be female.
- Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
- The tumor must have been pathologic primary invasive carcinoma by core needle or open biopsy.
- The beginning of endocrine therapy (letrozole or anastrozole) must be no more than 6 weeks from the end day of chemotherapy or radiotherapy.
Key exclusion criteria (11 listed)
- Presence of metastatic disease.
- Previous diagnosis of metachronous bilateral breast cancer.
- Previous or concomitant other (non-breast cancer) malignance within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell.
- Presence of other non-malignant disease which may prevent prolonged follow-up.
- Received neoadjuvant endocrine therapy.
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 |
|---|---|---|
| anastrozoleanastrozole 1 mg qd | Drug | A, B |
| letrozoleletrozole 2.5 mg qd | Drug | A, B |
| exemestaneexemestane 25 mg qd | Drug | A |
Primary outcome
disease free survival
Time frame: at 6, 12, 24, 36 months, then once every year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
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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.
Zhimin Shao, PhD, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing anastrozole, letrozole and exemestane in people with Breast Cancer, run by Fudan University at 1 site in China.
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 30 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 May 2009. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JinSong Lu (86-13661671885, lussjj@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: at 6, 12, 24, 36 months, then once every year). 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 15 May 2009.