Locally Advanced Breast CancerPhase 4PREDICTNCT00237133
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
A Phase 4 study testing Letrozole in people with Locally Advanced Breast Cancer, run by Novartis Pharmaceuticals at 11 sites in Brazil.
Trial summary
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 11 sitesBrazil
- Study dates
- Mar 2003to 21 Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Primary locally invasive breast cancer
- Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
- Post menopausal status
- Tumor measurable by clinical examination, mammography and ultrasound
Who cannot join
- Prior treatment with letrozole or tamoxifen.
- Patients with bilateral breast tumors
- Patients who are eligible for breast conserving surgery
- Evidence of inflammatory breast cancer or distant metastasis.
- Other concurrent malignant disease
- Concomitant anti-cancer treatments such as chemotherapy
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Novartis Investigative Site
Barretos - SP
Novartis Investigative Site
Florianopolis - SC
Novartis Investigative Site
Fortaleza/CE
Novartis Investigative Site
Goiania/GO
Novartis Investigative Site
Jau -SP
Novartis Investigative Site
Porto Alegre/RS
Novartis Investigative Site
Ribeirao - SP
Novartis Investigative Site
Rio de Janeiro
Novartis Investigative Site
Santo André
Novartis Investigative Site
Sao Paulo/SP
Novartis Investigative Site
Vitoria/ES
About this study
Official title: PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- Letrozole
- Keywords
- Breast cancer,, Letrozole,, Hormonal receptors
- 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
1 tablet of Letrozole 2.5 mg orally adminnistered once a day
| 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.
Safety and tolerability of Letrozole
Measured: frequency and severity of the clinical adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMar 2003
- Primary completionJan 2009
- Study completion21 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237133
- Sponsor's protocol ID
- CFEM345EBR01
- Acronym
- PREDICT
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2005
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
- ClinicalTrials.gov ID
- NCT00237133
- Acronym / sponsor ID
- PREDICT / CFEM345EBR01
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Breast cancer,, Letrozole,, Hormonal receptors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- 21 Jan 2009 (actual)
- First posted
- 12 Oct 2005 (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.
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women
- Primary locally invasive breast cancer
- Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
- Post menopausal status
- Tumor measurable by clinical examination, mammography and ultrasound
Key exclusion criteria (7 listed)
- Prior treatment with letrozole or tamoxifen.
- Patients with bilateral breast tumors
- Patients who are eligible for breast conserving surgery
- Evidence of inflammatory breast cancer or distant metastasis.
- Other concurrent malignant disease
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 |
|---|---|---|
| Letrozole1 tablet of Letrozole 2.5 mg orally adminnistered once a day | Drug | Letrozole |
Primary outcome
Safety and tolerability of Letrozole
Time frame: frequency and severity of the clinical adverse events
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 24 Feb 2017.
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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 Pharmaceuticals
11 sites 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 Locally Advanced Breast Cancer, run by Novartis Pharmaceuticals at 11 sites in Brazil.
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 5 inclusion and 7 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 24 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 11 sites in Brazil. 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?
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?
Safety and tolerability of Letrozole (time frame: frequency and severity of the clinical adverse events). 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 24 Feb 2017.