Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

NAActive, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 23, 2019

Primary Completion Date

August 18, 2024

Study Completion Date

October 23, 2027

Conditions
Breast Cancer Stage IVRadiotherapySurgery
Interventions
DRUG

Palbociclib

"The included patients will first receive the following systemic treatment according standard of care:~* Non-steroidal aromatase inhibitor (letrozole)~* Palbociclib~* Monthly Luteinizing hormone-releasing hormone (LHRH) analogue for non-menopausal patients only. Surgical bilateral oophorectomy is an acceptable option."

OTHER

locoregional treatment

After normally 6 courses of systemic treatment initiation, the loco-regional treatment of the primary tumour will be performed: surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy

Trial Locations (26)

13008

Hôpital St Joseph, Marseille

13009

Institut Paoli Calmettes, Marseille

21000

Centre George François Leclerc, Dijon

31059

Institut Claudius Regaud, Toulouse

34090

Hôpital saint Eloi CHU Montpellier, Montpellier

34298

ICM Val d'Aurelle, Montpellier

35042

Centre Eugène Marquis, Rennes

35760

Hôpital Privé à Saint Grégoire, Saint-Grégoire

49005

Institut de Cancérologie de l'Ouest-Site Paul Papin, Angers

49300

CH Cholet, Cholet

51726

Institut Jean Godinot, Reims

54519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

63000

Centre Jean Perrin, Clermont-Ferrand

64000

Centre Hospitalier de Pau, Pau

69008

Centre Léon Bérard, Lyon

71100

Hôpital privé sainte Marie, Chalon-sur-Saône

75005

Institut Curie Site Paris, Paris

75010

Hôpital Saint Louis APHP, Paris

75014

Hôpital St Joseph, Paris

75020

Hôpital Tenon, Paris

84818

Institut Sainte Catherine, Avignon

92210

Institut Curie Hôpital René Huguenin, Saint-Cloud

94800

Gustave Roussy, Villejuif

95000

CH René Dubos, Pontoise

95200

GCS RISSA - Institut de cancérologie Paris Nord, Sarcelles

Unknown

Centre François Baclesse, Caen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

UNICANCER

OTHER

NCT03870919 - Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients | Biotech Hunter | Biotech Hunter