brca1 Mutation CarrierPhase 2NCT00080756
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
A Phase 2 study testing therapeutic estradiol, deslorelin and therapeutic testosterone in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women. Read more about this study
- Who is it for?
- Ages 21 to 48 years, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
- What is being tested?
- therapeutic estradiol, deslorelin and therapeutic testosterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2004to 15 Oct 2024
- 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 21 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must generally be in good health with lab values and physical examination within normal limits
- Known high risk of breast cancer due to BRCA mutation or empiric risk > 30% lifetime by the Claus model
- No evidence or history of pervious cancer, except non-melanoma skin cancer
- Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
- Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
- Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
- Must be current non-smoker
Who cannot join
- GnRHA treatment within 12 months of study entry
- Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
- Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
- Pregnant or breast-feeding or have been so in the last six months
- Immeasurable breast density on mammogram
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.
PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
Read the detailed description
OBJECTIVES:
- Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.
II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.
OUTLINE:
GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.
GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
After completion of study treatment, patients are followed up every 6 months for 2 years.
- Being tested
- therapeutic estradiol, deslorelin, therapeutic testosterone, therapeutic conventional surgery, active surveillance
- Keywords
- breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic estradiolBiological
0.35mg/100ul per day as a nasal spray
deslorelinDrug
1mg/100ul per day as a nasal spray
therapeutic testosteroneDrug
0.275mg/100ul per day as a nasal spray
therapeutic conventional surgeryProcedure or surgery
Undergo risk reduction mastectomy
active surveillanceOther
Undergo continued surveillance
quality-of-life assessmentProcedure or surgery
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (planned risk reduction mastectomy) | Experimental | Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy. Receives: Biological: therapeutic estradiol; Drug: deslorelin; Drug: therapeutic testosterone; Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Group 2 (continued survaillance) | Active comparator | Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months. Receives: Biological: therapeutic estradiol; Drug: deslorelin; Drug: therapeutic testosterone; Other: active surveillance; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
Measured: Day 300
Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study start11 Mar 2004
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Weitzel, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080756
- Sponsor's protocol ID
- 02164
- Other IDs
- P30CA033572, CHNMC-IRB-02164, CDR0000355156, NCI-2011-00975
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2004
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
- ClinicalTrials.gov ID
- NCT00080756
- Acronym / sponsor ID
- 02164
- Keywords
- breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Mar 2004 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 8 Apr 2004 (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.
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.
PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
Detailed description
OBJECTIVES:
- Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.
II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.
OUTLINE:
GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.
GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (planned risk reduction mastectomy) | Experimental | Biological: therapeutic estradiol, Drug: deslorelin, Drug: therapeutic testosterone, Procedure: therapeutic conventional surgery, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy. |
| Group 2 (continued survaillance) | Active comparator | Biological: therapeutic estradiol, Drug: deslorelin, Drug: therapeutic testosterone, Other: active surveillance, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months. |
Who may qualify
- Ages
- 21 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must generally be in good health with lab values and physical examination within normal limits
- Known high risk of breast cancer due to BRCA mutation or empiric risk > 30% lifetime by the Claus model
- No evidence or history of pervious cancer, except non-melanoma skin cancer
- Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
- Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
Key exclusion criteria (5 listed)
- GnRHA treatment within 12 months of study entry
- Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
- Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
- Pregnant or breast-feeding or have been so in the last six months
- Immeasurable breast density on mammogram
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 |
|---|---|---|
| therapeutic estradiol0.35mg/100ul per day as a nasal spray | Biological | Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance) |
| deslorelin1mg/100ul per day as a nasal spray | Drug | Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance) |
| therapeutic testosterone0.275mg/100ul per day as a nasal spray | Drug | Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance) |
| therapeutic conventional surgeryUndergo risk reduction mastectomy | Procedure or surgery | Group 1 (planned risk reduction mastectomy) |
| active surveillanceUndergo continued surveillance | Other | Group 2 (continued survaillance) |
| quality-of-life assessmentAncillary studies | Procedure or surgery | Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance) |
| laboratory biomarker analysisCorrelative studies | Other | Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance) |
Primary outcome
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
Time frame: Day 300
Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Jeffrey Weitzel, MD principal investigator
City of Hope Medical Center
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 therapeutic estradiol, deslorelin and therapeutic testosterone in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by City of Hope Medical Center at 1 site in United States.
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 7 inclusion and 5 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 28 Aug 2024. 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 United States. 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?
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?
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300 (time frame: Day 300). The study lists 2 primary outcomes in all. 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 28 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.