Breast CancerPhase 2NCT00199134
FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole
A Phase 2 study testing Letrozole in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer; 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
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2004to Dec 2014
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female gender
- Post-menopausal(no age limit) defined as:
- Radiation-induced menopause or surgical bilateral oophorectomy, or
- Women with an intact uterus and
- > 55 years of age or ii. without menses for the last 5 years or iii. £ 55 years of age and has not had menses for at least the last 12 months (but has had menses in the last 5 years) and has postmenopausal levels of FSH c. Women without an intact uterus and i. > 55 years of age or ii. £ 55 years of age and has postmenopausal levels of FSH
- Contraindications for the use of neoadjuvant/adjuvant chemotherapy, refusal by the patient to receive chemotherapy or if the investigator believes the patient is a suitable candidate for this protocol.
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- WHO performance status < 1
- Histologically-confirmed ductal or lobular operable adenocarcinoma of the breast (stage I, II and III)
- Confirmed absence of liver, lung and bone metastases.
- Primary tumor of at least 2 cm, measured clinically and/or radiologically
- Multifocal invasive tumors are not eligible, unless a biopsy showing ER positivity can be obtained from each tumor lesion.
- ER-positive and/or PgR-positive tumors, defined according to immunohistochemistry (i.e. > 10% of positive cells after immunostaining), if woman younger 70 years; ER-positive or PgR-positive tumors if woman older than 70 years.
- Fixed and frozen samples from the primary tumor, obtained before treatment, must be available for evaluation of biological markers (cDNA microarrays, EGFR, HER-2, intra-tumoral aromatase).
- No concurrent second malignancy, including contralateral breast cancer (exceptions are: adequately treated basal cell carcinoma of the skin and in situ carcinoma of the cervix). Any prior second malignancy must be in remission for ³ 5 years.
- No other serious illness or medical condition including:
- History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (< 6 months) transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic greater than 100 mm Hg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
- Chronic lung disease
- History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
- Active concurrent infection
- No concurrent or previous anti-cancer treatment is allowed
- Adequate organ function as defined by:
- Neutrophils ³ 1.5 x 109/L
- Platelets ³ 100 x 109/L
- Bilirubin £ 1.5x upper limit of normal (ULN)
- Transaminases £ 2.5x ULN
- Creatinine £ 1.5x ULN
- Normal left ventricular ejection fraction by echocardiography or MUGA scan [for combination studies only]
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Before patient registration/randomization, informed consent must be given according to ICH/EU GCP, and national/local regulations.
Who cannot join
- Non specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FRAGRANCE Trial(Femara Reanalysed Through Genomics for Response Assessment, Calibration and Empowerment)
Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;
Read the detailed description
The aromatase inhibitors are drugs already approved for the treatment of breast cancer in the adjuvant and metastatic setting, and have demonstrated a superiority when compared to other hormone therapy agents as tamoxifen. FRAGRANCE is a trial of neoadjuvant hormone therapy activated in September 2004 at the Jules Bordet Institute. The main objective of this study is to find a genetic signature of de novo resistance to letrozole The standard dose of letrozol, 2,5 mg/day, is given orally during 4 months previous to the definitive breast surgery. The advantages of the neoadjuvant setting are a) the possibility to directly evaluate the response to therapy, which is of great value to decide adjuvant treatment; b) the increase chance of performing breast conserving surgery; c) and, because a tumor sample is obtained before and after treatment, the identification of predictive markers of response or resistance to treatment, including a genetic signature, obtained using the microarray technology. Eligible patients are women with early hormonal receptor positive breast cancer, with any contra-indication or refusal to the administration of chemotherapy The side effects of letrozole are already well known, and include more commonly hot flashes, nausea and vomiting, headache, arthralgia/myalgia, fatigue, and oedema. After surgery, adjuvant treatment will be done according to the standard practice of the Institute, considering the possibility of continuing letrozole for a total of at least 5 years, if a satisfactory response is achieved The first part of this trial will include 49 patients.
This trial will soon become a multicenter, multinational trial of 160 patients.
- Conditions
- Breast Cancer
- Being tested
- Letrozole
- Keywords
- neoadjuvant treatment
- 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
Size of the tumor is followed
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Other | Letrozole 2.5 mg per day Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate Pathologic complete response rate
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2014
- Study completionDec 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil, Hospital de Clinicas de Porto Alegre, Hospital do Cancer, Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Christos Sotiriou, MD, PhD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199134
- Sponsor's protocol ID
- FRAGRANCE
- Status last verified
- Dec 2014
- First submitted
- 12 Sep 2005
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAGRANCE Trial(Femara Reanalysed Through Genomics for Response Assessment, Calibration and Empowerment)
- ClinicalTrials.gov ID
- NCT00199134
- Acronym / sponsor ID
- FRAGRANCE
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil, Hospital de Clinicas de Porto Alegre, Hospital do Cancer, Sao Paulo
- Study start
- Nov 2004
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Sep 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.
Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;
Detailed description
The aromatase inhibitors are drugs already approved for the treatment of breast cancer in the adjuvant and metastatic setting, and have demonstrated a superiority when compared to other hormone therapy agents as tamoxifen. FRAGRANCE is a trial of neoadjuvant hormone therapy activated in September 2004 at the Jules Bordet Institute. The main objective of this study is to find a genetic signature of de novo resistance to letrozole The standard dose of letrozol, 2,5 mg/day, is given orally during 4 months previous to the definitive breast surgery. The advantages of the neoadjuvant setting are a) the possibility to directly evaluate the response to therapy, which is of great value to decide adjuvant treatment; b) the increase chance of performing breast conserving surgery; c) and, because a tumor sample is obtained before and after treatment, the identification of predictive markers of response or resistance to treatment, including a genetic signature, obtained using the microarray technology. Eligible patients are women with early hormonal receptor positive breast cancer, with any contra-indication or refusal to the administration of chemotherapy The side effects of letrozole are already well known, and include more commonly hot flashes, nausea and vomiting, headache, arthralgia/myalgia, fatigue, and oedema. After surgery, adjuvant treatment will be done according to the standard practice of the Institute, considering the possibility of continuing letrozole for a total of at least 5 years, if a satisfactory response is achieved The first part of this trial will include 49 patients.
This trial will soon become a multicenter, multinational trial of 160 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Other | Drug: LetrozoleLetrozole 2.5 mg per day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- Female gender
- Post-menopausal(no age limit) defined as:
- Contraindications for the use of neoadjuvant/adjuvant chemotherapy, refusal by the patient to receive chemotherapy or if the investigator believes the patient is a suitable candidate for this protocol.
- WHO performance status < 1
- Histologically-confirmed ductal or lobular operable adenocarcinoma of the breast (stage I, II and III)
Key exclusion criteria (1 listed)
- Non specified
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 |
|---|---|---|
| LetrozoleSize of the tumor is followed | Drug | Letrozole |
Primary outcome
Response Rate Pathologic complete response rate
Time frame: at the end of the study
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 6 Jan 2015.
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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.
Christos Sotiriou, MD, PhD study chair
Jules Bordet Institute
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 Letrozole in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 29 inclusion and 1 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 6 Jan 2015. 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 Belgium. 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 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?
Response Rate Pathologic complete response rate (time frame: at the end of the study). 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 6 Jan 2015.