Breast CancerTAMOXIFERTNCT02355600
Oocyte Recovery During Tamoxifen Adjuvant Therapy
An observational study of Breast Cancer, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Survival in young patients with cancer has increased and also have increased the adverse long-term side effects of chemotherapy, there is a large number of women who experience loss of ovarian function without accomplishing their reproductive desire due to gonadotoxic treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oocyte retrieval
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Dec 2020
- How long will I take part?
- 6 Years
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Young breast cancer patients (with positive estrogen receptors) using tamoxifen as adjuvant treatment
Who may be able to join
- Breast cancer patients whose tumors have positive hormone receptors (ER+) subsidiary of adjuvant treatment with tamoxifen
- Reproductive desire
Who cannot join
- Having received chemotherapy agents less than 12 months ago
- Current treatment with GnRH analogues
- Age > 35 years old
- Contraindication for follicular punction or hCG administration
Trial locations and contacts
1 site in 1 country.
César Diaz-Garcia, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
Ainhoa Romero, MD, ainhoa.romero.espinos@gmail.com
Ainhoa Romero Espinós, MD
About this study
Official title: Tamoxifen as Adjuvant Treatment in Breast Cancer and Its Impact on Ovarian Function
Survival in young patients with cancer has increased and also have increased the adverse long-term side effects of chemotherapy, there is a large number of women who experience loss of ovarian function without accomplishing their reproductive desire due to gonadotoxic treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation in fertility preservation treatments as well as in assisted reproduction techniques. Improving this reserve by avoiding its depletion during the process could result in increase fertility rates after cancer treatment.
Collecting follicles during tamoxifen treatment would increase the number of cryopreserved oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due to age, chemotherapy and length of treatments.
The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in breast cancer patients to improve the probability of subsequent pregnancy.
Read the detailed description
New chemotherapy regimens and management options developed during the last 20 years have yielded increased survival rates in cancer patients but they also cause side effects such as premature ovarian failure and infertility due to their gonadotoxicity. Hormone therapy also increases survival rates in breast cancer patients; tamoxifen, a selective estrogen receptor modulator, has been proven to reduce the risk of recurrence and mortality due to breast cancer when administered during 10 years.
The risk of premature ovarian failure depends not only on the gonadotoxicity of chemotherapy but also on the age of the patient, therefore although tamoxifen is not gonadotoxic itself, it can compromise fertility because of the long length of treatment and the subsequent delay in childbearing.
On the other hand, tamoxifen is a drug that can be used in assisted reproduction techniques to induce ovarian stimulation, therefore, the tamoxifen treatment followed by breast cancer patients represent somehow a way of continuous ovarian stimulation. If viable oocytes could be retrieved during the long-term hormonal treatment with tamoxifen, there will be an option to use them to restore fertility afterwards.
STUDY DESIGN:
Patients included in the study who have normal menstrual periods will be monitored by sonography (antral follicle count) and serum hormonal levels: E2 (oestradiol), P4 (progesterone), FSH (follicle stimulating hormone) and LH (luteinizing hormone) from the second day of their cycle. Patients without spontaneous menstruations will perform periodic visits every 15 days until images corresponding with antral follicle definition will be seen, this will be considered day 2 of the cycle.
Follow-up of the antral follicles will be done with sonography and serum hormonal levels according to the protocols of the investigators in vitro fertilization unit. When a follicle of more than 18 mm is seen, 250 µg of hCG (human chorionic gonadotropin) will be administered and 36 hours after, transvaginal oocyte retrieval will be performed. Oocyte and embryo quality assessment will be performed according to morphological ASEBIR (association for the study of reproduction biology) classification on day +2 and +3. Grade 1 and 2 embryos on day +3 will be cryopreserved.
Patients requiring assisted reproduction technologies to get pregnant after completion of their oncologic treatment will have their embryos thawed and subsequently transferred.
FOLLOW-UP:
During the time oocytes retrieved are being used or until the end of gestation in case the patient become pregnant.
Bearing in mind that most of the patients in our center undergo 5 year of tamoxifen treatment, it will be assumed a maximum follow-up of 6 years.
- Conditions
- Breast Cancer
- Being tested
- Oocyte retrieval
- Keywords
- Oocyte, Tamoxifen, Fertility preservation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrievalOther
Also called Oocyte pick-up
Tamoxifen given at a fixed dose for invasive breast cancer adjuvant hormonotherapy or for breast cancer prophylaxis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase II oocytes retrieved
Measured: 24 months
Secondary outcomes (3)
Number of frozen embryos
Measured: 24 months
Morphologic score of frozen embryos
Measured: 24 months
Pregnancy rate
pregnancy rates after the use of frozen embryos generated during tamoxifen treatment
Measured: Expected average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- César Diaz-Garcia, MD, Principal investigator, IIS La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355600
- Sponsor's protocol ID
- 2014/0642
- Acronym
- TAMOXIFERT
- Status last verified
- Sep 2016
- First submitted
- 22 Jan 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamoxifen as Adjuvant Treatment in Breast Cancer and Its Impact on Ovarian Function
- ClinicalTrials.gov ID
- NCT02355600
- Acronym / sponsor ID
- TAMOXIFERT / 2014/0642
- Conditions
- Breast Cancer
- Keywords
- Oocyte, Tamoxifen, Fertility preservation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Feb 2015 (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.
Survival in young patients with cancer has increased and also have increased the adverse long-term side effects of chemotherapy, there is a large number of women who experience loss of ovarian function without accomplishing their reproductive desire due to gonadotoxic treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation in fertility preservation treatments as well as in assisted reproduction techniques. Improving this reserve by avoiding its depletion during the process could result in increase fertility rates after cancer treatment.
Collecting follicles during tamoxifen treatment would increase the number of cryopreserved oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due to age, chemotherapy and length of treatments.
The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in breast cancer patients to improve the probability of subsequent pregnancy.
Detailed description
New chemotherapy regimens and management options developed during the last 20 years have yielded increased survival rates in cancer patients but they also cause side effects such as premature ovarian failure and infertility due to their gonadotoxicity. Hormone therapy also increases survival rates in breast cancer patients; tamoxifen, a selective estrogen receptor modulator, has been proven to reduce the risk of recurrence and mortality due to breast cancer when administered during 10 years.
The risk of premature ovarian failure depends not only on the gonadotoxicity of chemotherapy but also on the age of the patient, therefore although tamoxifen is not gonadotoxic itself, it can compromise fertility because of the long length of treatment and the subsequent delay in childbearing.
On the other hand, tamoxifen is a drug that can be used in assisted reproduction techniques to induce ovarian stimulation, therefore, the tamoxifen treatment followed by breast cancer patients represent somehow a way of continuous ovarian stimulation. If viable oocytes could be retrieved during the long-term hormonal treatment with tamoxifen, there will be an option to use them to restore fertility afterwards.
STUDY DESIGN:
Patients included in the study who have normal menstrual periods will be monitored by sonography (antral follicle count) and serum hormonal levels: E2 (oestradiol), P4 (progesterone), FSH (follicle stimulating hormone) and LH (luteinizing hormone) from the second day of their cycle. Patients without spontaneous menstruations will perform periodic visits every 15 days until images corresponding with antral follicle definition will be seen, this will be considered day 2 of the cycle.
Follow-up of the antral follicles will be done with sonography and serum hormonal levels according to the protocols of the investigators in vitro fertilization unit. When a follicle of more than 18 mm is seen, 250 µg of hCG (human chorionic gonadotropin) will be administered and 36 hours after, transvaginal oocyte retrieval will be performed. Oocyte and embryo quality assessment will be performed according to morphological ASEBIR (association for the study of reproduction biology) classification on day +2 and +3. Grade 1 and 2 embryos on day +3 will be cryopreserved.
Patients requiring assisted reproduction technologies to get pregnant after completion of their oncologic treatment will have their embryos thawed and subsequently transferred.
FOLLOW-UP:
During the time oocytes retrieved are being used or until the end of gestation in case the patient become pregnant.
Bearing in mind that most of the patients in our center undergo 5 year of tamoxifen treatment, it will be assumed a maximum follow-up of 6 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young breast cancer patients (with positive estrogen receptors) using tamoxifen as adjuvant treatment
Key inclusion criteria (2 listed)
- Breast cancer patients whose tumors have positive hormone receptors (ER+) subsidiary of adjuvant treatment with tamoxifen
- Reproductive desire
Key exclusion criteria (4 listed)
- Having received chemotherapy agents less than 12 months ago
- Current treatment with GnRH analogues
- Age > 35 years old
- Contraindication for follicular punction or hCG administration
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 |
|---|---|---|
| Oocyte retrievalAlso: Oocyte pick-upTamoxifen given at a fixed dose for invasive breast cancer adjuvant hormonotherapy or for breast cancer prophylaxis. | Other | – |
Primary outcome
Metaphase II oocytes retrieved
Time frame: 24 months
3 secondary outcomes
Number of frozen embryos
Time frame: 24 months
Morphologic score of frozen embryos
Time frame: 24 months
Pregnancy rate
Time frame: Expected average of 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
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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.
César Diaz-Garcia, MD contact
César Diaz-Garcia, MD principal investigator
IIS La Fe
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 Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 2 inclusion and 4 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 22 Sep 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact César Diaz-Garcia, MD (cesar.diaz@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metaphase II oocytes retrieved (time frame: 24 months). 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 22 Sep 2016.