Breast CancerPhase 4LEXTOPNCT01072318
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
A Phase 4 study testing Letrozole in people with Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jan 2014
- Phase
- Phase 4
- 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
- Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
- Removed the breast cancer histologically or cytologically
- No evidence of breast cancer in controlateral breast
- No evidence of metastasis
- Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
- Postmenopausal state was defined the following conditions, at least one of a, b
Show all 10Show fewer
- Serum FSH ≥ 30 mIU/mL
- Amenorrhea ≥ 1 year
- Estrogen receptor(+) or Progesterone receptor(+)
- No Evidence of Recurrence
Who cannot join
- Patient with hormone receptor negative
- Patients with malignancies
- Patients with other aromatase inhibitor and chemotherapy
- Patients with Other hormone therapy and Hormonal replacement therapy
- Patients with Hormone replacement therapy during taking Toremifene
- Estimated life expectancy of <12 months
Show all 9Show fewer
- WBC<3,000/mm3 or Platelet count<100,000/mm3
- AST and/or ALT ≥2xUNL
- Alkaline phosphatase ≥2xUNL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene
The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene
Read the detailed description
- Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene
- Secondary purpose
- To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.
- Disease Free Survival rate(DFS)-12 months, 24 months
- Distant disease free survival rate(DDFS), Overall Survival(OS)
- 12 months, 24 months, 36 months c. safety
- Change of lipid profiles
- Mortality and morbidity due to Cardiovascular disease
- Incidence of Fracture
- Change of Bone density
- Common toxic effect
- Conditions
- Breast Cancer
- Being tested
- Letrozole
- Keywords
- Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
Letrozole 2.5mg
| Study group | Role | What they receive |
|---|---|---|
| Letrozole, DFS | Experimental | Efficacy evaluation of extended letrozole after 5 year fareston use Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival rate
Measured: 3 years
Secondary outcomes (4)
Disease free survival rate
Measured: 12 months, 24 months
Distant disease free survival rate
Measured: 12 months, 24 months, 36 months
Overall survival rate
Measured: 12, 24, 36 months
Toxicity was assessed by NCI-CTC version 3.0
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Sei-Hyun Ahn, MD, Principal investigator, Department of Surgery, Asan medical center, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072318
- Sponsor's protocol ID
- KBCSG007
- Acronym
- LEXTOP
- Status last verified
- Feb 2010
- First submitted
- 14 Feb 2010
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene
- ClinicalTrials.gov ID
- NCT01072318
- Acronym / sponsor ID
- LEXTOP / KBCSG007
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 22 Feb 2010 (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 assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene
Detailed description
- Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene
- Secondary purpose
- To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.
- Disease Free Survival rate(DFS)-12 months, 24 months
- Distant disease free survival rate(DDFS), Overall Survival(OS)
- 12 months, 24 months, 36 months c. safety
- Change of lipid profiles
- Mortality and morbidity due to Cardiovascular disease
- Incidence of Fracture
- Change of Bone density
- Common toxic effect
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole, DFS | Experimental | Drug: LetrozoleEfficacy evaluation of extended letrozole after 5 year fareston use |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
- Removed the breast cancer histologically or cytologically
- No evidence of breast cancer in controlateral breast
- No evidence of metastasis
- Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
Key exclusion criteria (9 listed)
- Patient with hormone receptor negative
- Patients with malignancies
- Patients with other aromatase inhibitor and chemotherapy
- Patients with Other hormone therapy and Hormonal replacement therapy
- Patients with Hormone replacement therapy during taking Toremifene
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 |
|---|---|---|
| LetrozoleAlso: FemaraLetrozole 2.5mg | Drug | Letrozole, DFS |
Primary outcome
Disease free survival rate
Time frame: 3 years
4 secondary outcomes
Disease free survival rate
Time frame: 12 months, 24 months
Distant disease free survival rate
Time frame: 12 months, 24 months, 36 months
Overall survival rate
Time frame: 12, 24, 36 months
Toxicity was assessed by NCI-CTC version 3.0
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2010.
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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.
Sei-Hyun Ahn, MD principal investigator
Department of Surgery, Asan medical center, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole in people with Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
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 10 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: status not confirmed, as of the sponsor's last update on 22 Feb 2010. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Disease free survival rate (time frame: 3 years). 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 22 Feb 2010.