Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
100
Countries
1
Sites
8
Breast cancer
To assess the feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH followed by oocyte vitrification and/or embryo freezing prior to chemotherapy for breast cancer
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Feb 2025 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ICO funding
External identifiers
- EU CT number
- 2024-516282-37-00
- EudraCT number
- 2013-001981-40
- ClinicalTrials.gov
- NCT02890082
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To assess the feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH followed by oocyte vitrification and/or embryo freezing prior to chemotherapy for breast cancer
Secondary objectives 6
- Evaluate the average time to the start of chemotherapy
- To assess the impact of the type of stimulation on the number and quality of oocytes and/or embryos collected (phase of the cycle at the start of stimulation)
- Impact of ovarian stimulation on recurrence and 10-year survival
- Evaluate the number of pregnancies
- Descriptive analysis of previous parameters in women who have accepted fertility preservation
- Ancillary study: To assess the impact of TAM pharmacokinetics on ovarian stimulation in a subgroup of 50 patients (recruitment in Nantes only).
Conditions and MedDRA coding
Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- 1. Obtaining signed informed consent prior to any trial-specific procedure
- 2. Between 18 and 40 yo
- 3. Histologically proven invasive breast carcinoma
- 4. Indication for adjuvant or neoadjuvant chemotherapy validated by pre-therapy PCR
- 5. T0-T1-T2-T3
- 6. N0-N1-N2a
- 7. M0 after extension assessment according to French INCa recommendations
- 8. AMH (anti-müllerian hormone) ≥1 ng/mL and/or AFC (antral follicle count) ≥ 5 (on ultrasound: ovaries puncturable transvaginally),
- 9. HIV serology negative
- 10. Social protection
Exclusion criteria 7
- 1. Previous breast cancer
- 2. History of any other cancer in the last 5 years, with the exception of basal cell and squamous cell skin cancers
- 3. Pregnancy in progress
- 4. Pulmonary embolism less than 6 months old
- 5. Deep vein thrombosis less than 6 months old
- 6. Dementia or altered mental state
- 7. Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the subject from understanding the study and signing the consent form (art. L.1121-6, L.1211-8, L.1211-9).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.
Secondary endpoints 4
- Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment
- Overall survival / event-free survival at 10 years.
- Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies.
- Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
NOLVADEX 10 mg, comprimé pelliculé
PRD373031 · Product
- Active substance
- Tamoxifen Citrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02BA01 — TAMOXIFEN
- Marketing authorisation
- VNL 10803
- MA holder
- ASTRAZENECA S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Puregon 300 IU/0.36 mL solution for injection
PRD9022782 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 U unit(s)
- Max total dose
- 3600 U unit(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/038
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cetrotide 0.25 mg powder and solvent for solution for injection
PRD3311118 · Product
- Active substance
- Cetrorelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 3000 µg microgram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC02 — CETRORELIX
- Marketing authorisation
- EU/1/99/100/002
- MA holder
- MERCK EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovitrelle 250 micrograms solution for injection in pre-filled pen
PRD3312176 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 250 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/008
- MA holder
- MERCK EUROPE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- Boulevard Jacques Monod
- City
- Saint-Herblain Cedex
- Postcode
- 44805
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Aliette DEZELLUS
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Marine TIGREAT
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 100 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Gynecologie, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Nantes
Gynecologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre De Lutte Contre Le Cancer Eugene Marquis
Gynecologie, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Centre Hospitalier Universitaire De Rennes
Gynecologie, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Universitaire D'Angers
Gynecologie, 4 Rue Larrey, 49100, Angers
Centre Jean Perrin
Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
University Hospital Of Clermont-Ferrand
Gynecologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-02-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_2013-01981-40_ Protocole_FR_V3_20220408_PRESAGE | 3 |
| Protocol (for publication) | D1_Annexe 4 - Formulaire de SAE ICO-DRCI_01-01-12 v1 | 1 |
| Protocol (for publication) | D1_Annexe 5 - CTC v4 | 4 |
| Recruitment arrangements (for publication) | K1_2013-001981-40_Informed consent patient recruitment procedure_20240710_PRESAGE | 1 |
| Recruitment arrangements (for publication) | K2013-01981-40_Courrier investigateurs et centres PMA pour reprise des reimplantations_V1 1_20220425 | 1 |
| Subject information and informed consent form (for publication) | L1_NIFC_ V1 1 du 15-07-13_PRESAGE | 1.1 |
| Subject information and informed consent form (for publication) | L2_2013-01981-40_3b Addendum lettre info MSA pour toutes les patientes_V1 1_20220425_PRESAGE | 1.1 |
| Subject information and informed consent form (for publication) | L2_Annexe 3 bis - Nantes- cst PK TAM V1 du 02-12-13 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_RCP NOLVADEX | 1 |
| Synopsis of the protocol (for publication) | D1_2013-01981-40_1 Resume_FR_V3_20220408_PRESAGE | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-11 | France | Acceptable 2024-08-09
|
2024-08-09 |