Clinical Trials Register

Summary
EudraCT Number:	2016-000808-28
Sponsor's Protocol Code Number:	2015-01
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2018-10-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2016-000808-28

A.3

Full title of the trial

Risk of infertility related to adjuvant chemotherapy in young breast cancer patients: Oocyte/embryo cryopreservation

Chimiothérapie adjuvante et risque d’infertilité chez les jeunes patientes présentant un cancer du sein: Place de la cryopréservation ovocytaire ou embryonnaire

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Place de la stimulation ovarienne chez des jeunes patientes atteintes d'un cancer du sein devant recevoir une chimiothérapie adjuvante pouvant amener à une infertilité.

A.3.2

Name or abbreviated title of the trial where available

CHACRY

A.4.1

Sponsor's protocol code number

2015-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Centre Oscar Lambret
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	INCa
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Centre Oscar Lambret
B.5.2	Functional name of contact point	UIRC - Cellule Promotion
B.5.3	Address:
B.5.3.1	Street Address	3, rue frédéric Combemale
B.5.3.2	Town/ city	Lille cedex
B.5.3.3	Post code	59020
B.5.3.4	Country	France
B.5.4	Telephone number	33(0)320295918
B.5.5	Fax number	33(0)320295896
B.5.6	E-mail	promotion@o-lambret.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Follitropine alpha et beta
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cancer du sein chez la femme jeune

E.1.1.1

Medical condition in easily understood language

Cancer du sein chez la femme jeune

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10006188
E.1.2	Term	Breast cancer female NOS
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluer l’efficacité d’une congélation d’ovocytes et/ou d’embryons après hyperstimulation ovarienne contrôlée chez des patientes jeunes présentant un cancer du sein qui recevront une chimiothérapie adjuvante.

E.2.2

Secondary objectives of the trial

Evaluer la qualité des ovocytes préservés
Evaluer le risque oncologique et reproductif de l’hyperstimulation ovarienne contrôlée
Evaluer la gonadotoxicté de la chimiothérapie
Evaluer l'incidence et la durée de l'aménorrhée induite par la chimiothérapie
Mesurer le taux de projets de grossesse ultérieure aboutis
Evaluer le nombre de patientes qui souhaitent la ré-utilisation de leurs gamètes congelés
Mesurer la survie sans progression
Etudier l'impact psychologique et la qualité de vie

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Identifier de nouveaux biomarqueurs non-invasifs de la réserve ovarienne

E.3

Principal inclusion criteria

-Femme présentant un cancer du sein histologiquement prouvé (quelque soit le grade, le type histologique et le statut HER2)
-Agée de 18 à 38 ans
-Relevant d’un traitement par chimiothérapie adjuvante : 3 (F)EC100 suivis de 3 Taxotère +/- Trastuzmab
-Numération de la formule sanguine, fonctions hépatique et rénale adéquates :
•Hemoglobine ≥ 10 G/100 mL
•Neutrophiles ≥ 1500 /mm3
•Plaquettes ≥ 100 000 /mm3
•Urée ≤ 1.5 x LSN (Limite supérieure de la normale)
•Clairance de la créatinine ≥ 45 ml/min ou créatinine ≤ 1.5 x LSN
•Bilirubine totale ≤ LSN
•SGOT/SGPT ≤ 1.5 x LSN
•Phosphatases Alcalines ≤ 2.5 x LSN
•GGT ≤ 1.5 x LSN
•LDH ≤ 1.5 x LSN
-Pas de traitement antérieur par chimiothérapie pour le présent cancer
-Bénéficiaire d’un régime de sécurité sociale
-Consentement éclairé et signé par la patiente avant la mise en place de toute procédure spécifique à l’étude

E.4

Principal exclusion criteria

-Cancer du sein métastatique
-Antécédent d’hystérectomie
-Hormonothérapie
-Sérologie positive pour la syphilis, l’hépatite B ou C, ou le VIH
-Femme enceinte ou allaitante
-Incapacité de la patiente à se soumettre au suivi médical (raison géographique, sociale ou psychique)

E.5 End points

E.5.1

Primary end point(s)

Qualité des ovocytes ou embryons : nombre total d’ovocytes ou embryons préservés / nombre total d’ovocytes ou embryons

E.5.1.1

Timepoint(s) of evaluation of this end point

fin d'étude

E.5.2

Secondary end point(s)

- Type d’ovocytes: mature, immature, atrétique
- Toxicité reliée à la stimulation ovarienne (syndrome d’hyperstimulation)
- Dosage de l’hormone anti-millerienne (AMH) et compte des follicules antraux (CFA)
- Nombre de grossesses spontanées ou médicalement assistées
- Nombre de ré-utilisation de gamètes congelés
- Survie sans progression
- Echelles psychosociales : EORTC QLQ-C30, IN-PATSAT32, SAQ, HADS, MFI20 et consultation psychologique

E.5.2.1

Timepoint(s) of evaluation of this end point

fin d'étude

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Date de suivi de la dernière patiente incluse dans l'étude

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	132
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-10-12.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	132

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-06-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-15

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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