The objective of this pilot-study is to investigate if the current dosage of tamoxifen supplied to women with estrogen receptor positive breastcancer who opt for embryo- or oocyte freezing is protective during the whole period of hormone stimulation…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the serum endoxifen level during the whole
period of ovarian hyperstimulation.
The endoxifen level is a binary outcome measure, a level < 7 ng/ml = supposed
to be insufficient E2 blockade.
Secondary outcome
Baseline characteristics, ovarian hyperstimulation, the resulting number and
quality of embryos and oocytes frozen. Data with regard to the cycle day, hour
of tamoxifen intake and the hour of blood sample and follicle-fluid collections
for measurement of active tamoxifen-metabolites are collected as well.
Background summary
Significant medical advances in cancer treatment have improved survival rates
in female cancer survivors of reproductive age and as a consequence, the wish
to have children has become increasingly important. Fertility preservation
techniques (e.g. ovarian, embryo and oocyte freezing) are now available to
increase chances of further childhood, and these techniques need to be
performed just prior to gonadotoxic treatment, like radiotherapy or
chemotherapy.
The Centre for Reproductive Medicine, AMC, employs embryo and oocyte freezing.
Women who opt for embryo or oocyte freezing will receive hormone stimulation
with GnRH analogues and recombinant FSH injections during a 2-3 weeks period
and subsequently undergo ovum pick up with the aim to freeze embryos or
oocytes.
In women with breast cancer and estrogen positive hormone receptors,
hormone-stimulation may induce extra growth of cancer cells. The additional use
of 60 mg of tamoxifen is supposed to block the effect of high estrogen levels.
Until now it is unknown what dosage of tamoxifen is regarded as a sufficient to
protect women for the high levels of estrogens that arise during ovarian
hyperstimulation. In this pilot-study we will investigate the protective
effect of Tamoxifen by measuring the level of its active metabolites (
endoxifen, N-desmethyltamoxifen, 4-hydroxytamoxifen, 4*-hydroxytamoxifen en
N-desmethyl-4*-hydroxytamoxifen). Below a certain endoxifen level (< 7 ng/ml)
the estrogen receptor modulation in estrogen sensitive breast cancer receptors
is supposed to be insufficient. To this aim we want to investigate if the
dosage of tamoxifen given is protective during the whole period of hormone
stimulation.
Study objective
The objective of this pilot-study is to investigate if the current dosage of
tamoxifen supplied to women with estrogen receptor positive breastcancer who
opt for embryo- or oocyte freezing is protective during the whole period of
hormone stimulation.
Study design
Tamoxifen (60 mg daily) is administered to women who opt for embryo or oocyte
freezing who suffer from breast cancer and estrogen positive hormone receptors.
During ovarian hyperstimulation, four to five blood samples in these women are
taken on a routine base with measurements of the levels of estradiol (E2) and
luteinizing hormone (LH) in order to measure the effect of ovarian stimulation.
After given informed consent, an extra blood sample is collected at every
moment of routine blood collection to the aim of measuren the concentrations of
active tamoxifen-metabolites (endoxifen, N-desmethyltamoxifen,
4-hydroxytamoxifen, 4*-hydroxytamoxifen en N-desmethyl-4*-hydroxytamoxifen). We
will also perform measurements of these metabolites in remained follicle-fluid
that is collected after ovum-pick up.
Study burden and risks
There are no risks associated with participation of the study.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Women who are of reproductive age (18- 40 yrs), who suffer from estrogen- receptor positive breast cancer and opt for embryo- or oocyte freezing.
Exclusion criteria
1)Women who are unwilling or unable to sign the informed consent form
2)Women who are not in good enough medical condition to undergo ovarian hormone stimulation and ovum pick up.
3) Women who need medication which opposes the efficacy of tamoxifen (e.g. fluotexine)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35447.018.11 |