BRCA1 MutationNCT00700778
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
A study testing recombinant human chorionic gonadotropin, microarray analysis and immunohistochemistry staining method in people with BRCA1 Mutation and Breast Cancer, run by Fox Chase Cancer Center at 3 sites in 2 countries.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- BRCA1 Mutation, Breast Cancer
- What is being tested?
- recombinant human chorionic gonadotropin, microarray analysis and immunohistochemistry staining method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2008to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Asymptomatic women who have a deleterious mutation on the BRCA1 gene
- Normal, no complaints, no evidence of disease
- Nulliparous, never pregnant (G0P0)
- No previous diagnosis of breast or ovarian cancer
- No known brain metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100%
- Premenopausal with normal menstrual cycles and intact ovaries
- Normal ovarian size report from pelvic ultrasound
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to human chorionic gonadotropin preparations or one of its excipients
- No uncontrolled intercurrent illness including any of the following:
- Ovarian enlargement of undetermined origin
- Ovarian cysts > 2 cm
- Microcystic ovaries, which might predispose to the development of ovarian hyperstimulation syndrome
- History of prior cancer other than non-melanoma skin cancer
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Severe cognitive deficit or psychiatric illness/social situations that would make her unable to give informed consent or would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- At least 6 weeks since prior and no concurrent oral contraceptives or hormone-replacement therapy
- No concurrent tamoxifen for chemoprevention
- No concurrent participation in another chemopreventive trial for breast cancer
- No concurrent medication that could interfere with this study including any of the following:
- Hormonal contraceptives
- Androgens
- Prednisone
- Thyroid hormones
- Insulin
- No other concurrent investigational agents
- No recent treatment with follicle-stimulating hormone for assisted reproduction
- No HIV-positive patients on concurrent combination antiretroviral therapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in preventing breast cancer in premenopausal women with BRCA1 mutations.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk.
Secondary
- Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes that would serve as biomarkers indicative of decreased breast cancer risk.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
- Conditions
- BRCA1 Mutation, Breast Cancer
- Being tested
- recombinant human chorionic gonadotropin, microarray analysis, immunohistochemistry staining method, laboratory biomarker analysis, needle biopsy
- Keywords
- breast cancer, BRCA1 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.
recombinant human chorionic gonadotropinBiological
microarray analysisGenetic
laboratory biomarker analysisOther
needle biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human chorionic gonadotropin | Experimental | Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity. Receives: Biological: recombinant human chorionic gonadotropin; Genetic: microarray analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline
Measured: 90 days and 270 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Unable to recruit volunteers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jose Russo, MD, FCAP, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700778
- Sponsor's protocol ID
- 06827
- Other IDs
- 06827, R21CA124522
- Status last verified
- Jan 2021
- First submitted
- 18 Jun 2008
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
- ClinicalTrials.gov ID
- NCT00700778
- Acronym / sponsor ID
- 06827
- Conditions
- BRCA1 Mutation, Breast Cancer
- Keywords
- breast cancer, BRCA1 mutation carrier
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit volunteers
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in preventing breast cancer in premenopausal women with BRCA1 mutations.
Detailed description
OBJECTIVES:
Primary
- Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk.
Secondary
- Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes that would serve as biomarkers indicative of decreased breast cancer risk.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant human chorionic gonadotropin | Experimental | Biological: recombinant human chorionic gonadotropin, Genetic: microarray analysis, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: needle biopsyPatients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| recombinant human chorionic gonadotropin | Biological | Recombinant human chorionic gonadotropin |
| microarray analysis | Genetic | Recombinant human chorionic gonadotropin |
| immunohistochemistry staining method | Other | Recombinant human chorionic gonadotropin |
| laboratory biomarker analysis | Other | Recombinant human chorionic gonadotropin |
| needle biopsy | Procedure or surgery | Recombinant human chorionic gonadotropin |
Primary outcome
Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline
Time frame: 90 days and 270 days from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jose Russo, MD, FCAP principal investigator
Fox Chase Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant human chorionic gonadotropin, microarray analysis and immunohistochemistry staining method in people with BRCA1 Mutation and Breast Cancer, run by Fox Chase Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Austria. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline (time frame: 90 days and 270 days from baseline). 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 25 Jan 2021.