Breast CancerPhase 2PRESAGENCT02890082
Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer
A Phase 2 study testing Tamoxifen stim in early follicular phase, Tamoxifen stim in late follicular phase and Tamoxifen stim in luteal phase in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments. Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen stim in early follicular phase, Tamoxifen stim in late follicular phase and Tamoxifen stim in luteal phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 40
- infiltrating breast carcinoma histologically proven
- Indication of adjuvant or neoadjuvant chemotherapy
- T0-T1-T2-T3
- N0-N1-N2a
- M0 after staging
- AMH ≥1 ng / mL and / or account antral follicles ≥ 5
- HIV serology negative.
Who cannot join
- breast cancer history
- History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell
- patient in pregnancy
- pulmonary embolism under 6 months
- deep vein thrombosis of less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.
Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.
Read more
PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.
The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.
This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.
Read the detailed description
With 50 000 new cases per year, breast cancer is the most common cancer in women in France. About a quarter of breast cancers occurs before menopause and 7% before the age of 40 years. Due to the increased incidence of breast cancer in young women and declining age of first pregnancy, it is not unusual to have patient desiring pregnancy after treatment of a breast cancer. Among these women, the use of adjuvant therapy (chemotherapy, hormone therapy, chemical castration) is common. Adjuvant or neoadjuvant chemotherapy resulted in significantly lower recurrence rates and increase the survival of these patients, but these treatments could have more or less long-term consequences, including in ovarian function. Ovarian consequences of these therapeutic must also be explained to young patients. But it seems that this information is often inadequate or poorly understood, and then patients deplore to be faced with secondary infertility.
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.
Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.
PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.
The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.
This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen stim in early follicular phase, Tamoxifen stim in late follicular phase, Tamoxifen stim in luteal phase
- Keywords
- Breast cancer, fertility, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen stim in early follicular phaseDrug
Also called Hormotherapy
Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3
- Stimulation with simultaneously: TAM (tamoxifen) 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve)
- Monitoring (ultrasound + blood test E2, LH (luteinizing hormone) and P) every 2 to 3 days +/- dose adjustment of FSH
- Ovulation by blocking the GnRH antagonist (gonadotropin-releasing hormone : CETROTIDE) introduced according to the usual criteria,
- Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days
- Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
- 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.
Tamoxifen stim in late follicular phaseDrug
Also called Hormotherapy
Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14
- Monitoring (ultrasound + blood test E2, LH and P) until a follicle of 15 mm
- Ovulation induction by OVITRELLE® 250μg.
- Continued monitoring (ultrasound + blood test E2, LH and P) 4 days after OVITRELLE® to the proper stage for the beginning of stimulation.
- Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
- Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
- Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
- 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.
Tamoxifen stim in luteal phaseDrug
Also called Hormotherapy
Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28
- 1 or 2 Monitoring (ultrasound + blood test E2, LH and P) to check the validity of the post-ovulatory phase
- Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
- Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
- Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
- 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen stim in early follicular phase | Experimental | Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3 Receives: Drug: Tamoxifen stim in early follicular phase |
| Tamoxifen stim in late follicular phase | Other | Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14 Receives: Drug: Tamoxifen stim in late follicular phase |
| Tamoxifen stim in luteal phase | Other | Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28 Receives: Drug: Tamoxifen stim in luteal phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.
=> evaluated by number of oocytes and / or embryos per patient.
Measured: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)
Secondary outcomes (1)
number of pregnancy obtain
Measured: At least 2 years After chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startFeb 2014
- Primary completion17 Jul 2017
- Study completionJan 2028 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORDES Virginie, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890082
- Sponsor's protocol ID
- ICO-N-2013-03
- Acronym
- PRESAGE
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2016
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02890082
- Acronym / sponsor ID
- PRESAGE / ICO-N-2013-03
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, fertility, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Sep 2016 (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.
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.
Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.
PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.
The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.
This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.
Detailed description
With 50 000 new cases per year, breast cancer is the most common cancer in women in France. About a quarter of breast cancers occurs before menopause and 7% before the age of 40 years. Due to the increased incidence of breast cancer in young women and declining age of first pregnancy, it is not unusual to have patient desiring pregnancy after treatment of a breast cancer. Among these women, the use of adjuvant therapy (chemotherapy, hormone therapy, chemical castration) is common. Adjuvant or neoadjuvant chemotherapy resulted in significantly lower recurrence rates and increase the survival of these patients, but these treatments could have more or less long-term consequences, including in ovarian function. Ovarian consequences of these therapeutic must also be explained to young patients. But it seems that this information is often inadequate or poorly understood, and then patients deplore to be faced with secondary infertility.
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.
Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.
PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.
The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.
This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen stim in early follicular phase | Experimental | Drug: Tamoxifen stim in early follicular phaseDay cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3 |
| Tamoxifen stim in late follicular phase | Other | Drug: Tamoxifen stim in late follicular phaseDay cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14 |
| Tamoxifen stim in luteal phase | Other | Drug: Tamoxifen stim in luteal phaseDay cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged between 18 and 40
- infiltrating breast carcinoma histologically proven
- Indication of adjuvant or neoadjuvant chemotherapy
- T0-T1-T2-T3
- N0-N1-N2a
Key exclusion criteria (5 listed)
- breast cancer history
- History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell
- patient in pregnancy
- pulmonary embolism under 6 months
- deep vein thrombosis of less than 6 months.
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 |
|---|---|---|
| Tamoxifen stim in early follicular phaseAlso: HormotherapyDay cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3 * Stimulation with simultaneously: TAM (tamoxifen) 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) * Monitoring (ultrasound + blood test E2, LH (luteinizing hormone) and P) every 2 to 3 days +/- dose adjustment of FSH * Ovulation by blocking the GnRH antagonist (gonadotropin-releasing hormone : CETROTIDE) introduced according to the usual criteria, * Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days * Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria * 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia. | Drug | Tamoxifen stim in early follicular phase |
| Tamoxifen stim in late follicular phaseAlso: HormotherapyDay cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14 * Monitoring (ultrasound + blood test E2, LH and P) until a follicle of 15 mm * Ovulation induction by OVITRELLE® 250μg. * Continued monitoring (ultrasound + blood test E2, LH and P) 4 days after OVITRELLE® to the proper stage for the beginning of stimulation. * Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE * Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH * Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria * 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia. | Drug | Tamoxifen stim in late follicular phase |
| Tamoxifen stim in luteal phaseAlso: HormotherapyDay cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28 * 1 or 2 Monitoring (ultrasound + blood test E2, LH and P) to check the validity of the post-ovulatory phase * Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE * Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH * Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria * 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia | Drug | Tamoxifen stim in luteal phase |
Primary outcome
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.
Time frame: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer. => evaluated by number of oocytes and / or embryos per patient.
1 secondary outcome
number of pregnancy obtain
Time frame: At least 2 years After chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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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.
BORDES Virginie, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen stim in early follicular phase, Tamoxifen stim in late follicular phase and Tamoxifen stim in luteal phase in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer. (time frame: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)). 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 31 Mar 2026.