Breast CancerPhase 3NCT00330317
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
A Phase 3 study testing letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in United Kingdom.
Trial summary
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, 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
- 300 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- Feb 2006to 16 Nov 2010
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
- Clinical stage T2 or >T2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
- Postmenopausal status defined by one of the following:
- Women with an intact uterus AND
- ≥ 55 years of age, OR
- < 55 years of age without menses for the last 5 years, OR
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- < 55 years of age and have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone.
- Women without an intact uterus AND
- ≥ 55 years of age, OR
- < 55 years of age and postmenopausal levels of follicle-stimulating hormone
- Both ovaries removed (prior to the diagnosis of breast cancer).
- Tumour measurable by clinical examination, mammography and ultrasound
- Adequate bone marrow function as shown by:
- WBC ≥ 3.5 x 10^9/L
- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ LLN
- Hb > 10 g/dL
Who cannot join
- Multifocal disease (cancer that starts in several different sites)
- Patients with bilateral breast tumours.
- Patients who are eligible for breast conserving surgery.
- Evidence of inflammatory breast cancer or distant metastasis.
- Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.
- The following additional treatments are NOT allowed during the treatment phase of the study:
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- Any other anti-cancer therapy
- Hormone replacement therapy.
- Estrogen cream (including any intra-vaginal preparation).
- Steroids other than creams or inhalers.
- Megestrol acetate for the treatment of hot flushes.
- Radiation therapy.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Novartis Investigative Site
Bournemouth
Novartis Investigative Site
Brighton
Novartis Investigative Site
Bristol
Novartis Investigative Site
Crewe
Novartis Investigative Site
Dundee
Novartis Investigative Site
East Sussex
Novartis Investigative Site
Epping
Novartis Investigative Site
Farnworth
Novartis Investigative Site
Gateshead
Novartis Investigative Site
Glasgow
Novartis Investigative Site
Hants
Novartis Investigative Site
Leicester
Novartis Investigative Site
Liverpool
Novartis Investigative Site
London
Novartis Investigative Site
Luton
Novartis Investigative Site
Manchester
Novartis Investigative Site
Newcastle
Novartis Investigative Site
Poole
Novartis Investigative Site
Saint Leonards-on-Sea
Novartis Investigative Site
West Smithfield
About this study
Official title: Neoadjuvant Hormone Therapy for Postmenopausal Women With HR+ Primary Breast Cancer: A Multi-center Study to Determine the Optimum Length of Treatment With Letrozole on Tumour Regression to Permit Breast Conserving Surgery.
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
- Conditions
- Breast Cancer
- Being tested
- letrozole
- Keywords
- Letrozole, Breast Conserving Surgery, NeoAdjuvant, Early 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.
letrozoleDrug
Also called Femara, FEM345
2.5mg letrozole once-daily
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Not described Receives: Drug: letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
Measured: 12 months
Secondary outcomes (4)
Reduction in tumour volume every 2 months throughout the study
Measured: 12 months
Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria
Measured: 12 months
Long term (5-year) local recurrence rate
Measured: 5 years
Safety and tolerability of the treatment prior to surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2010
- Study completion16 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330317
- Sponsor's protocol ID
- CFEM345EGB07
- Status last verified
- Feb 2017
- First submitted
- 24 May 2006
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Carpenter R, Doughty JC, Cordiner C, Moss N, Gandhi A, Wilson C, Andrews C, Ellis G, Gui G, Skene AI. Optimum duration of neoadjuvant letrozole to permit breast conserving surgery. Breast Cancer Res Treat. 2014 Apr;144(3):569-76. doi: 10.1007/s10549-014-2835-8. Epub 2014 Feb 23.
PubMed 24562823
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Hormone Therapy for Postmenopausal Women With HR+ Primary Breast Cancer: A Multi-center Study to Determine the Optimum Length of Treatment With Letrozole on Tumour Regression to Permit Breast Conserving Surgery.
- ClinicalTrials.gov ID
- NCT00330317
- Acronym / sponsor ID
- CFEM345EGB07
- Conditions
- Breast Cancer
- Keywords
- Letrozole, Breast Conserving Surgery, NeoAdjuvant, Early Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- 16 Nov 2010 (actual)
- First posted
- 26 May 2006 (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 aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: letrozole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
- Clinical stage T2 or >T2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
- Postmenopausal status defined by one of the following:
- Tumour measurable by clinical examination, mammography and ultrasound
- Adequate bone marrow function as shown by:
Key exclusion criteria (13 listed)
- Multifocal disease (cancer that starts in several different sites)
- Patients with bilateral breast tumours.
- Patients who are eligible for breast conserving surgery.
- Evidence of inflammatory breast cancer or distant metastasis.
- Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.
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: Femara, FEM3452.5mg letrozole once-daily | Drug | Letrozole |
Primary outcome
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
Time frame: 12 months
4 secondary outcomes
Reduction in tumour volume every 2 months throughout the study
Time frame: 12 months
Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria
Time frame: 12 months
Long term (5-year) local recurrence rate
Time frame: 5 years
Safety and tolerability of the treatment prior to surgery
Time frame: 5 years
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 7 Feb 2017.
- Results publication: PubMed 24562823Carpenter R, Doughty JC, Cordiner C, Moss N, Gandhi A, Wilson C, Andrews C, Ellis G, Gui G, Skene AI. Optimum duration of neoadjuvant letrozole to permit breast conserving surgery. Breast Cancer Res Treat. 2014 Apr;144(3):569-76. doi: 10.1007/s10549-014-2835-8. Epub 2014 Feb 23.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in United Kingdom.
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 17 inclusion and 13 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: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom. 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?
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.
What does the primary outcome measure?
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330317, which also lists 1 linked publication.
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 7 Feb 2017.