Clinical trial • Phase II • Oncology

EXEMESTANE for Luminal A breast cancer | Hormone receptor-positive (HR+) HER2-negative breast cancer

Phase II trial of EXEMESTANE for Luminal A breast cancer | Hormone receptor-positive (HR+) HER2-negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Luminal A breast cancer | Hormone receptor-positive (HR+) HER2-negative breast cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-05-2024
First CTIS Authorization Date
05-06-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 46 sites in France.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True (MammaPrint® / Blueprint®; strata include "ultra-low" risk vs other risk categories [low/high] as used for screening and secondary analyses)
Target Sample Size
776
Trial Duration For Participant
1825

Eligibility

Recruits 776 The study enrolls adult postmenopausal women only; written informed consent is required prior to any trial-specific procedures. "When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent." Persons deprived of their liberty or under protective custody or guardianship are excluded. isVulnerablePopulationSelected: false.

Vulnerable Population
The study enrolls adult postmenopausal women only; written informed consent is required prior to any trial-specific procedures. "When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent." Persons deprived of their liberty or under protective custody or guardianship are excluded. isVulnerablePopulationSelected: false

Inclusion criteria

  • {"criterion_text":"- Postmenopausal women: Postmenopausal status is defined by any of the following: - Prior bilateral oophorectomy - Age ≥60 years - Age >50 and <60 years and amenorrheic for at least 12 months, and folliclestimulating hormone (FSH) and estradiol in the postmenopausal range"}
  • {"criterion_text":"- IHC expression of the estrogen receptor and/or progesterone receptor ≥50%"}
  • {"criterion_text":"- HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified])"}
  • {"criterion_text":"- No indication of adjuvant chemotherapy"}
  • {"criterion_text":"- Patient considered has having a luminal A ultralow risk of metastatic recurrence (i.e. less than 5% risk of metastatic relapse at 10 years) according to MammaPrint® and Blueprint® tests."}
  • {"criterion_text":"- pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2"}
  • {"criterion_text":"- Patients eligible to receive or have recently started (with a maximum of 4 months of adjuvant hormone therapy prior to enrollment) an adjuvant hormone therapy (letrozole, anastrozole, or exemestane)"}
  • {"criterion_text":"- Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures"}
  • {"criterion_text":"- Patients must be affiliated to a Social Security System (or equivalent)"}
  • {"criterion_text":"- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-1"}
  • {"criterion_text":"- Women with histologically proven invasive unilateral breast cancer"}
  • {"criterion_text":"- M0: Not clinically nor radiologically detectable metastases at time of inclusion"}
  • {"criterion_text":"- Primary tumor completely resected and adequate axillary surgery performed, according to current standards"}

Exclusion criteria

  • {"criterion_text":"- Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment"}
  • {"criterion_text":"- Patients unwilling or unable to comply with trial obligations for geographic, social, physical or psychological reasons, or who are unable to understand the purpose and procedures of the trial"}
  • {"criterion_text":"- Persons deprived of their liberty or under protective custody or guardianship"}
  • {"criterion_text":"- Any local or regional recurrence or metastatic disease"}
  • {"criterion_text":"- Non-invasive carcinoma"}
  • {"criterion_text":"- Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer"}
  • {"criterion_text":"- Patients with a history of another malignancy without complete remission for more than 5 years, except for properly treated cervical carcinoma in situ and non-melanoma cancer of the skin"}
  • {"criterion_text":"- Women with high-risk breast cancer predisposing deleterious germline mutations"}
  • {"criterion_text":"- Contra-indications to the administration of anti-aromatase inhibitors"}
  • {"criterion_text":"- Patients enrolled in another therapeutic study within 30 days of inclusion"}
  • {"criterion_text":"- Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Distant relapse–free interval (DRFI) defined as the time from date of beginning of hormonotherapy to the date of first event of distant recurrence or breast cancer related death.","definition_or_measurement_approach":"Time from date of beginning of hormonotherapy to date of first event of distant recurrence or breast cancer-related death (i.e., event-driven time-to-event endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- Invasive disease-free survival (iDFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Invasive breast cancer–free survival (iBCFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Breast cancer specific survival (BCSS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Assess QoL at baseline and annually up to 5 years (per secondary objectives: general QoL, fatigue, psychological, geriatric characteristics for patients aged >=75 years, and cognitive functions)."}
  • {"endpoint_text":"- Safety: Adverse Events will be graded according to NCI-CTCAE v5.0","definition_or_measurement_approach":"Adverse events graded per NCI-CTCAE v5.0"}
  • {"endpoint_text":"- Distant Disease-Free Survival (DDFS)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
776
Recruitment Window Months
136
Consent Approach
Written informed consent is required from each participant prior to any trial-specific procedures. If a patient is physically unable to provide written consent, a trusted person of her choice, independent from the investigator or sponsor, may confirm the patient’s consent in writing. Subject information and informed consent forms (SIS/ICF) are provided (documents available in the trial dossier); plain language protocol synopses are available in French and English. No assent process (no paediatric participants).

Geography

Total Number Of Sites
46
Total Number Of Participants
776

France

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
29-04-2025
Processing Time Days
343
Number Of Sites
46
Number Of Participants
776

Sites

Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie
Principal Investigator Name
Christophe PERRIN
Principal Investigator Email
c.perrin@rennes.unicancer.fr
Contact Person Name
Christophe PERRIN
Contact Person Email
c.perrin@rennes.unicancer.fr
Site Name
Hopital Européen
Department Name
Oncologie
Principal Investigator Name
Julien BARROU
Principal Investigator Email
julien.barrou@gmail.com
Contact Person Name
Julien BARROU
Contact Person Email
julien.barrou@gmail.com
Site Name
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Department Name
Oncologie
Principal Investigator Name
Pascal KO KIVOK YUN
Principal Investigator Email
pascal.ko-kivok-yun@ch-mdm.fr
Contact Person Name
Pascal KO KIVOK YUN
Contact Person Email
pascal.ko-kivok-yun@ch-mdm.fr
Site Name
Clinique Sainte Clotilde
Department Name
RADIOTHERAPIE
Principal Investigator Name
Mickael BEGUE
Principal Investigator Email
mickael.begue@clinifutur.net
Contact Person Name
Mickael BEGUE
Contact Person Email
mickael.begue@clinifutur.net
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncologie
Principal Investigator Name
Thomas GRELLETY
Principal Investigator Email
tgrellety@ch-cotebasque.fr
Contact Person Name
Thomas GRELLETY
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie
Principal Investigator Name
Aurore GOINEAU
Principal Investigator Email
aurore.goineau@ico.unicancer.fr
Contact Person Name
Aurore GOINEAU
Site Name
Institut Gustave Roussy
Department Name
Oncologie
Principal Investigator Name
Benjamin Verret
Principal Investigator Email
BENJAMIN.VERRET@gustaveroussy.fr
Contact Person Name
Benjamin Verret
Site Name
Centre azureen de cancerologie
Department Name
Oncologie
Principal Investigator Name
Philippe RONCHIN
Principal Investigator Email
ronchinp@yahoo.fr
Contact Person Name
Philippe RONCHIN
Contact Person Email
ronchinp@yahoo.fr
Site Name
Centre Hospitalier De Cholet
Department Name
Oncologie
Principal Investigator Name
Victor SIMMET
Principal Investigator Email
victor.simmet@ch-cholet.fr
Contact Person Name
Victor SIMMET
Contact Person Email
victor.simmet@ch-cholet.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie
Principal Investigator Name
Fernando BAZAN
Principal Investigator Email
fernando.bazan@clermont.unicancer.fr
Contact Person Name
Fernando BAZAN
Site Name
Institut Bergonie
Department Name
Oncologie
Principal Investigator Name
Camille CHAKIBA
Principal Investigator Email
c.chakiba@bordeaux.unicancer.fr
Contact Person Name
Camille CHAKIBA
Site Name
Centre Hospitalier Simone Veil De Beauvais
Department Name
Oncologie
Principal Investigator Name
Hanifa AMMARGUELLAT
Principal Investigator Email
h.ammarguellat@ch-beauvais.fr
Contact Person Name
Hanifa AMMARGUELLAT
Contact Person Email
h.ammarguellat@ch-beauvais.fr
Site Name
Centre Oscar Lambret
Department Name
Oncologie
Principal Investigator Name
Emilie KACZMAREK
Principal Investigator Email
e-kaczmarek@o-lambret.fr
Contact Person Name
Emilie KACZMAREK
Contact Person Email
e-kaczmarek@o-lambret.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Oncologie
Principal Investigator Name
Gaetan de RAUGLAUDRE
Principal Investigator Email
a.rollet@isc84.org
Contact Person Name
Gaetan de RAUGLAUDRE
Contact Person Email
a.rollet@isc84.org
Site Name
Centre Hospitalier De Bourg-En-Bresse
Department Name
Oncologie
Principal Investigator Name
Hubert ORFEUVRE
Principal Investigator Email
horfeuvre@ch-bourg01.fr
Contact Person Name
Hubert ORFEUVRE
Contact Person Email
horfeuvre@ch-bourg01.fr
Site Name
Centre hospitalier de Brive
Department Name
Oncologie
Principal Investigator Name
Christel BRETON CALLU
Principal Investigator Email
christel.breton-callu@ch-brive.fr
Contact Person Name
Christel BRETON CALLU
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Oncologie
Principal Investigator Name
Audrey Keller
Principal Investigator Email
Keller.Audrey@iuct-oncopole.fr
Contact Person Name
Audrey Keller
Contact Person Email
Keller.Audrey@iuct-oncopole.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Oncologie
Principal Investigator Name
Carole PFLUIO
Principal Investigator Email
c.pflumio@icans.eu
Contact Person Name
Carole PFLUIO
Contact Person Email
c.pflumio@icans.eu
Site Name
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Department Name
Oncologie
Principal Investigator Name
Danièle FRIC
Principal Investigator Email
daniele.fric@avec.fr
Contact Person Name
Danièle FRIC
Contact Person Email
daniele.fric@avec.fr
Site Name
Groupe de Radiothérapie et d'Oncologie des Pyrénées
Department Name
RADIOTHERAPIE
Principal Investigator Name
Marie-Ange PROUDHOM
Principal Investigator Email
dr.proudhorm@grop64.fr
Contact Person Name
Marie-Ange PROUDHOM
Contact Person Email
dr.proudhorm@grop64.fr
Site Name
Polyclinique De Limoges
Department Name
Oncologie
Principal Investigator Name
Dominique Genet
Principal Investigator Email
dg@imagemed-87.com
Contact Person Name
Dominique Genet
Contact Person Email
dg@imagemed-87.com
Site Name
Clinique Mutualiste de l'Estuaire
Department Name
Oncologie
Principal Investigator Name
Marie-Gabrielle SALIOU
Principal Investigator Email
marie.saliou@hospigrandouest.fr
Contact Person Name
Marie-Gabrielle SALIOU
Site Name
Hopital Prive Drome-Ardeche
Department Name
Oncologie
Principal Investigator Name
Stéphane LANTHEAUME
Principal Investigator Email
stephane.lantheaume@ramsaysante.fr
Contact Person Name
Stéphane LANTHEAUME
Site Name
Clinique du Pont Saint-Vaast
Department Name
Oncologie
Principal Investigator Name
Natacha Stern
Principal Investigator Email
nstern@clinique-psv.fr
Contact Person Name
Natacha Stern
Contact Person Email
nstern@clinique-psv.fr
Site Name
Centre de Radiothérapuie-oncologie de Moyenne Garonne
Department Name
Oncologie
Principal Investigator Name
Olivier BERNARD
Principal Investigator Email
o.bernard@crmg-agen.fr
Contact Person Name
Olivier BERNARD
Contact Person Email
o.bernard@crmg-agen.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie
Principal Investigator Name
Elise DELUCHE
Principal Investigator Email
elise.deluche@chu-limoges.fr
Contact Person Name
Elise DELUCHE
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Centre Georges-François Leclerc
Department Name
Oncologie
Principal Investigator Name
Coureche KADERBHAI
Principal Investigator Email
cgkaderbha1@cgfl.fr
Contact Person Name
Coureche KADERBHAI
Contact Person Email
cgkaderbha1@cgfl.fr
Site Name
Centre Hospitalier Metropole Savoie
Department Name
Oncologie
Principal Investigator Name
Serge DANHIER
Principal Investigator Email
serge.danhier@ch-metropole-savoie.fr
Contact Person Name
Serge DANHIER
Site Name
Centre Hospitalier D Auxerre
Department Name
Oncologie
Principal Investigator Name
Adina Marti
Principal Investigator Email
amarti@ch-auxerre.fr
Contact Person Name
Adina Marti
Contact Person Email
amarti@ch-auxerre.fr
Site Name
Groupe Hospitalier Rance Emeraude
Department Name
ONCOLOGIE MEDICALE
Principal Investigator Name
Hervé DESCLOS
Principal Investigator Email
h.desclos@ch-stmalo.fr
Contact Person Name
Hervé DESCLOS
Contact Person Email
h.desclos@ch-stmalo.fr
Site Name
Centre Francois Baclesse
Department Name
Oncologie
Principal Investigator Name
George EMILE
Principal Investigator Email
g.emile@baclesse.unicancer.fr
Contact Person Name
George EMILE
Contact Person Email
g.emile@baclesse.unicancer.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Oncologie
Principal Investigator Name
Johan Kristiansen
Principal Investigator Email
jkristiansen@ch-annecygenevois.fr
Contact Person Name
Johan Kristiansen
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie
Principal Investigator Name
Nicolas ISAMBERT
Principal Investigator Email
nicolas.isambert@chu-poitiers.fr
Contact Person Name
Nicolas ISAMBERT
Site Name
Clinique Medico Chirurgicale Charcot
Department Name
CHIRURGIE-GYNECOLOGIE-SENOLOGIE
Principal Investigator Name
Nicolas CARRABAIN
Principal Investigator Email
fse-carrabin@clinique-charcot.fr
Contact Person Name
Nicolas CARRABAIN
Site Name
Institut Paoli Calmettes
Department Name
Oncologie
Principal Investigator Name
Frédéric VIRET
Principal Investigator Email
viretf@ipc.unicancer.fr
Contact Person Name
Frédéric VIRET
Contact Person Email
viretf@ipc.unicancer.fr
Site Name
Reseau De Sante Mutualiste
Department Name
Oncologie
Principal Investigator Name
Victor PASSERAT
Principal Investigator Email
v.passerat@free.fr
Contact Person Name
Victor PASSERAT
Contact Person Email
v.passerat@free.fr
Site Name
Centre Hospitalier de Grasse
Department Name
GYNECOLOGUE OBSTETRICIEN
Principal Investigator Name
Anne-Sophie AZUAR
Principal Investigator Email
as.azuar@ch-grasse.fr
Contact Person Name
Anne-Sophie AZUAR
Contact Person Email
as.azuar@ch-grasse.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Oncologie
Principal Investigator Name
Léa MUZELLEC
Principal Investigator Email
lea.muzellec@ch-cornouaille.fr
Contact Person Name
Léa MUZELLEC
Contact Person Email
lea.muzellec@ch-cornouaille.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie
Principal Investigator Name
Caroline BAILLEUX
Principal Investigator Email
caroline.bailleux@nice.unicancer.fr
Contact Person Name
Caroline BAILLEUX
Site Name
Hopital NOVO
Department Name
Oncologie
Principal Investigator Name
Sophie VAUTIER RIT
Principal Investigator Email
sophie.vautier-rit@ght-novo.fr
Contact Person Name
Sophie VAUTIER RIT
Contact Person Email
sophie.vautier-rit@ght-novo.fr
Site Name
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Department Name
Oncologie
Principal Investigator Name
Nathalie PEREZ-STAUB
Principal Investigator Email
nathalie.perez-staub@cognacq-jay.fr
Contact Person Name
Nathalie PEREZ-STAUB
Site Name
Centre Hospitalier De Pau
Department Name
Oncologie
Principal Investigator Name
Kevin BOURCIER
Principal Investigator Email
kevin.bourcier@ch-pau.fr
Contact Person Name
Kevin BOURCIER
Contact Person Email
kevin.bourcier@ch-pau.fr
Site Name
Centre Hospitalier Metropole Savoie (Saint-Herblain entry)
Department Name
Oncologie
Principal Investigator Name
Augustin MERVOYER
Principal Investigator Email
augustin.mervoyer@ico.unicancer.fr
Contact Person Name
Augustin MERVOYER
Site Name
Centre Hospitalier Blois Simone Veil
Department Name
Oncologie
Principal Investigator Name
Olivier ARSENE
Principal Investigator Email
arseneo@ch-blois.fr
Contact Person Name
Olivier ARSENE
Contact Person Email
arseneo@ch-blois.fr
Site Name
Clinique Pasteur Lanroze
Department Name
Oncologie
Principal Investigator Name
Margaux QUENTEL
Principal Investigator Email
margaux.quentel@oncologie-brest.fr
Contact Person Name
Margaux QUENTEL
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Oncologie
Principal Investigator Name
Romuald LE SCODAN
Principal Investigator Email
rlescodan@vivalto-sante.com
Contact Person Name
Romuald LE SCODAN
Contact Person Email
rlescodan@vivalto-sante.com
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
Oncologie
Principal Investigator Name
Andy Schimtt
Principal Investigator Email
aschmitt@ch-aix.fr
Contact Person Name
Andy Schimtt
Contact Person Email
aschmitt@ch-aix.fr
Site Name
Centre Leon Berard
Department Name
Oncologie
Principal Investigator Name
Severine RACADOT
Principal Investigator Email
severine.racadot@lyon.unicancer.fr
Contact Person Name
Severine RACADOT
Site Name
Clinique des Cèdres
Department Name
Oncologie
Principal Investigator Name
Iona CARPUIC
Principal Investigator Email
icarpiuc@capio.fr
Contact Person Name
Iona CARPUIC
Contact Person Email
icarpiuc@capio.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Oncologie
Principal Investigator Name
Olfa DERBEL
Principal Investigator Email
o.derbelmermoz@gmail.com
Contact Person Name
Olfa DERBEL
Contact Person Email
o.derbelmermoz@gmail.com

Sponsor

Primary sponsor

Full Name
Unicancer
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
EXEMESTANE
Active Substance
EXEMESTANE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
No marketing authorisation number provided (marketingAuthNumber: "-")
Frequency
daily
Maximum Dose
25 mg
Investigational Product Name
ANASTROZOLE
Active Substance
ANASTROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
No marketing authorisation number provided (marketingAuthNumber: "-")
Frequency
daily
Maximum Dose
1 mg
Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
No marketing authorisation number provided (marketingAuthNumber: "-")
Frequency
daily
Maximum Dose
2.5 mg

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