Breast CancerNCT00644683
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
An observational study of Breast Cancer, run by Lynn Henry at 1 site in United States.
Trial summary
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2013
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.
Who may be able to join
- Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
- Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
- Patients must have:
- Reached their 25th birthday and not yet reached their 51st birthday at the time of study enrollment, AND
- Had menses within 3 months prior to starting chemotherapy
- Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
Show all 10Show fewer
- Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
- ECOG performance status 0 - 2
- Pregnant or nursing women may not participate. Women of reproductive potential must agree to use an effective non-hormonal contraceptive method, such as condoms, tubal ligation, non-hormonal intrauterine device, partner sterilization, and abstinence during chemotherapy.
- All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries.
In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
- Conditions
- Breast Cancer
- Keywords
- premenopausal women with breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
estimates of serum concentrations
To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy.
Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy
Measured: 1 year
Secondary outcomes (1)
serum concentrations of reproductive hormones
To determine serum concentrations of reproductive hormones (estradiol and its metabolites) before, immediately after, and 1 year following completion of chemotherapy using standard estradiol assays, and compare these results to those obtained using metabolomics.
Hypothesis: Serum concentrations of reproductive hormones (estradiol and its metabolites) will be detectable in all premenopausal women before chemotherapy, and will decrease immediately after chemotherapy in a considerable subset of patients. In addition, metabolomics will provide the same information about the presence or absence of estrogens, and will also provide additional data about other compounds present in the serum.
2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Henry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lynn Henry, University of Michigan Rogel Cancer Center
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644683
- Sponsor's protocol ID
- UMCC 2007.081
- Other IDs
- HUM 00014246
- Status last verified
- Jun 2014
- First submitted
- 17 Jan 2008
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Henry NL, Xia R, Schott AF, McConnell D, Banerjee M, Hayes DF. Prediction of postchemotherapy ovarian function using markers of ovarian reserve. Oncologist. 2014 Jan;19(1):68-74. doi: 10.1634/theoncologist.2013-0145. Epub 2013 Dec 6.
PubMed 24319018
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
- ClinicalTrials.gov ID
- NCT00644683
- Acronym / sponsor ID
- UMCC 2007.081
- Conditions
- Breast Cancer
- Keywords
- premenopausal women with breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lynn HenryUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Mar 2008 (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.
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries.
In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.
Key inclusion criteria (10 listed)
- Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
- Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
- Patients must have:
- Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
- Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
Key exclusion criteria (0 listed)
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
estimates of serum concentrations
Time frame: 1 year
To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy. Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy
1 secondary outcome
serum concentrations of reproductive hormones
Time frame: 1 year
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 Jun 2014.
- Results publication: PubMed 24319018Henry NL, Xia R, Schott AF, McConnell D, Banerjee M, Hayes DF. Prediction of postchemotherapy ovarian function using markers of ovarian reserve. Oncologist. 2014 Jan;19(1):68-74. doi: 10.1634/theoncologist.2013-0145. Epub 2013 Dec 6.
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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, MD, PhD principal investigator
University of Michigan
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, run by Lynn Henry 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 10 inclusion and 0 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 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 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?
estimates of serum concentrations (time frame: 1 year). 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 NCT00644683, 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 6 Jun 2014.