Breast CancerNCT01384526
Investigating the Impact of Tamoxifen Therapy on Ovarian Aging
An observational study of Breast Cancer and Fertility, run by University of California, San Francisco at 1 site in United States.
Trial summary
Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer, Fertility
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2015
- Phase
- Observational
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The UCSF Cancer Registry will be screened for female patients who were treated at the UCSF Breast Care Center between 1985 and 2010 and who meet the eligibility criteria listed below.
Who may be able to join
- Female
- ≥25 years of age at the time of study enrollment
- Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ, or determined to be high risk for primary breast cancer
- If endocrine therapy was used, women must have completed at least 2 years of endocrine therapy as defined by either
- Tamoxifen alone
- Ovarian suppression plus tamoxifen or aromatase inhibitor
Show all 11Show fewer
- Ovarian suppression alone
- Women must have been premenopausal at the time of endocrine therapy initiation. Premenopausal is defined as having had a menstrual cycle within 12 months before starting treatment.
- For the biomarker assessments, patients must be off all endocrine therapy (tamoxifen, ovarian suppression with goserelin or leuprolide, or aromatase inhibitor) for at least 6 months prior to study enrollment.
- For the biomarker assessments, patient must be off hormone contraceptives, fertility treatments, or other hormone therapies for at least 3 months prior to study enrollment
- For the biomarker assessments, patient must have had regular periods the last 3 months.
Who cannot join
- Evidence for either local recurrence following use of adjuvant systemic therapy or evidence for distant recurrence of breast cancer.
- Prior history of ovarian surgery or manipulation
- Mother with premature ovarian failure as defined by onset of menopause at age <40
- Prior chemotherapy exposure
- Prior history of endometriosis, anovulation or documented infertility
- Pregnant at the time of study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. The purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on age and menopausal status. Women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. The age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging (OVA) study.
- Conditions
- Breast Cancer, Fertility
- Keywords
- hormone therapy, ovarian aging, ovarian reserve, fertility, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| history of hormone therapy | Not described | |
| no history of hormone therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
age of menopause onset
The primary aim of this study is to determine the mean age of menopause onset in a cohort of women who have completed a course of tamoxifen therapy and to compare this age with the accepted national average age of natural menopause. Age of menopause onset which is defined as the year of the last menstrual period minus patient's birth year.
Measured: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
Secondary outcomes (3)
biomarkers of ovarian reserve
A secondary aim is to compare biomarkers of ovarian reserve in premenopausal women between ages 25-45 who have been previously treated with tamoxifen with those of age- and ethnicity-matched healthy controls. The primary biomarker of interest is antral follicle count (AFC). Other biomarkers that will be measured include anti-Mullerian hormone (AMH), inhibin B, FSH, and estradiol levels.
Measured: assessed at time of ultrasound and blood draw (single day appointment, 1 hour)
reproductive history
A secondary aim is to characterize the reproductive histories of women who have completed a course of endocrine therapy for the prevention or treatment of breast cancer.
Measured: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
lifestyle factors, medical history, and demographics
A secondary aim is to correlate biomarkers of ovarian age and age of menopause onset with lifestyle factors, medical history, and demographics in pre- and postmenopausal women previously treated with endocrine therapy, accounting for age and ethnicity.
Measured: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionMar 2015
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.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Jo Chien, MD, Principal investigator, University of California, San FranciscoMitch Rosen, MD, Principal investigator, UCSF Center for Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384526
- Sponsor's protocol ID
- 025950
- Status last verified
- Mar 2015
- First submitted
- 24 Jun 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Tamoxifen Therapy on Ovarian Aging
- ClinicalTrials.gov ID
- NCT01384526
- Acronym / sponsor ID
- 025950
- Conditions
- Breast Cancer, Fertility
- Keywords
- hormone therapy, ovarian aging, ovarian reserve, fertility, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jun 2011 (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.
Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. The purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on age and menopausal status. Women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. The age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging (OVA) study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| history of hormone therapy | – | – |
| no history of hormone therapy | – | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The UCSF Cancer Registry will be screened for female patients who were treated at the UCSF Breast Care Center between 1985 and 2010 and who meet the eligibility criteria listed below.
Key inclusion criteria (11 listed)
- Female
- ≥25 years of age at the time of study enrollment
- Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ, or determined to be high risk for primary breast cancer
- If endocrine therapy was used, women must have completed at least 2 years of endocrine therapy as defined by either
- Women must have been premenopausal at the time of endocrine therapy initiation. Premenopausal is defined as having had a menstrual cycle within 12 months before starting treatment.
Key exclusion criteria (6 listed)
- Evidence for either local recurrence following use of adjuvant systemic therapy or evidence for distant recurrence of breast cancer.
- Prior history of ovarian surgery or manipulation
- Mother with premature ovarian failure as defined by onset of menopause at age <40
- Prior chemotherapy exposure
- Prior history of endometriosis, anovulation or documented infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
age of menopause onset
Time frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
The primary aim of this study is to determine the mean age of menopause onset in a cohort of women who have completed a course of tamoxifen therapy and to compare this age with the accepted national average age of natural menopause. Age of menopause onset which is defined as the year of the last menstrual period minus patient's birth year.
3 secondary outcomes
biomarkers of ovarian reserve
Time frame: assessed at time of ultrasound and blood draw (single day appointment, 1 hour)
reproductive history
Time frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
lifestyle factors, medical history, and demographics
Time frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment)
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 9 Mar 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.
A. Jo Chien, MD principal investigator
University of California, San Francisco
Mitch Rosen, MD principal investigator
UCSF Center for Reproductive Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Fertility, run by University of California, San Francisco 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 11 inclusion and 6 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 9 Mar 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 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.
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?
age of menopause onset (time frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment)). 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 9 Mar 2015.