Breast CancerPhase 2NCT00555477
Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
A Phase 2 study testing anastrozole in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.
Trial summary
Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Sep 2013
- Phase
- Phase 2
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for this study:
- You must be at least 18 years of age and not older than 60 years of age
- You have breast cancer which was confined to the breast and lymph nodes under the arm, and have no evidence of cancer elsewhere
- You must have had surgical removal of your tumor, and if indicated, radiation therapy must have been completed or planned
- Your tumor must express estrogen and/or progesterone receptors
- You must have had a menstrual period within 6 months before starting chemotherapy for your breast cancer.
- You must have been treated with a chemotherapy regimen that includes cyclophosphamide (Cytoxan). Your menstrual periods must have stopped for at least 8 weeks starting during or after chemotherapy.
Who cannot join
- You are not eligible to participate in this study if:
- 1. Your ovaries have been surgically removed, treated with radiation therapy, or if you are taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sidney Kimmel Comprehensive Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
About this study
Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors.
In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study.
The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.
- Conditions
- Breast Cancer
- Being tested
- anastrozole
- Keywords
- premenopausal breast cancer with chemotherapy-induced ovarian failure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
Also called Arimidex
1 mg tablet by mouth once a day
| Study group | Role | What they receive |
|---|---|---|
| anastrozole | Experimental | Not described Receives: Drug: anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy
In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2011
- Study completionSep 2013
Why it stopped: The study was stopped after 69 subjects were enrolled because of poor accrual.
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.
- 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 University of Michigan Rogel 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Henry, University of Michigan Rogel Cancer Center
- Investigators
- Norah L. Henry, M.D., Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555477
- Sponsor's protocol ID
- UMCC 2007.044
- Other IDs
- HUM 12443
- Status last verified
- May 2014
- First submitted
- 6 Nov 2007
- Last updated
- 19 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Henry NL, Xia R, Banerjee M, Gersch C, McConnell D, Giacherio D, Schott AF, Pearlman M, Stearns V, Partridge AH, Hayes DF. Predictors of recovery of ovarian function during aromatase inhibitor therapy. Ann Oncol. 2013 Aug;24(8):2011-6. doi: 10.1093/annonc/mdt149. Epub 2013 Apr 23.
PubMed 23613476
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
- ClinicalTrials.gov ID
- NCT00555477
- Acronym / sponsor ID
- UMCC 2007.044
- Conditions
- Breast Cancer
- Keywords
- premenopausal breast cancer with chemotherapy-induced ovarian failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped after 69 subjects were enrolled because of poor accrual.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Posted 19 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors.
In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study.
The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anastrozole | Experimental | Drug: anastrozole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- You must be at least 18 years of age and not older than 60 years of age
- You have breast cancer which was confined to the breast and lymph nodes under the arm, and have no evidence of cancer elsewhere
- You must have had surgical removal of your tumor, and if indicated, radiation therapy must have been completed or planned
- Your tumor must express estrogen and/or progesterone receptors
- You must have had a menstrual period within 6 months before starting chemotherapy for your breast cancer.
Key exclusion criteria (2 listed)
- 1. Your ovaries have been surgically removed, treated with radiation therapy, or if you are taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.
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 |
|---|---|---|
| anastrozoleAlso: Arimidex1 mg tablet by mouth once a day | Drug | anastrozole |
Primary outcome
The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy
Time frame: 12 months
In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23613476Henry NL, Xia R, Banerjee M, Gersch C, McConnell D, Giacherio D, Schott AF, Pearlman M, Stearns V, Partridge AH, Hayes DF. Predictors of recovery of ovarian function during aromatase inhibitor therapy. Ann Oncol. 2013 Aug;24(8):2011-6. doi: 10.1093/annonc/mdt149. Epub 2013 Apr 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.
Norah L. Henry, M.D., Ph.D. principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anastrozole in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 3 sites 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 2 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: stopped early, as of the sponsor's last update on 19 Jun 2014. 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. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2014). 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?
The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy (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 NCT00555477, 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 19 Jun 2014.