A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

August 14, 2024

Primary Completion Date

September 9, 2031

Study Completion Date

September 9, 2031

Conditions
Breast Cancer
Interventions
DRUG

[68Ga]Ga-NeoB

68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions.

DRUG

[177Lu]Lu-NeoB

\[177Lu\]Lu-NeoB is a radioligand therapy drug.

DRUG

Capecitabine

Capecitabine is a chemotherapy drug.

Trial Locations (32)

2010

RECRUITING

Novartis Investigative Site, Darlinghurst

3144

RECRUITING

Novartis Investigative Site, Malvern

28041

RECRUITING

Novartis Investigative Site, Madrid

33076

RECRUITING

Novartis Investigative Site, Bordeaux

38043

RECRUITING

Novartis Investigative Site, Grenoble

41013

RECRUITING

Novartis Investigative Site, Seville

42123

RECRUITING

Novartis Investigative Site, Reggio Emilia

44805

RECRUITING

Novartis Investigative Site, Saint-Herblain

45147

RECRUITING

Novartis Investigative Site, Essen

47014

RECRUITING

Novartis Investigative Site, Meldola

53792

RECRUITING

University Of Wisconsin, Madison

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

67200

RECRUITING

Novartis Investigative Site, Strasbourg

72076

RECRUITING

Novartis Investigative Site, Tübingen

77030

RECRUITING

Uni Of TX MD Anderson Cancer Cntr, Houston

90095

RECRUITING

UCLA Medical Center, Los Angeles

91054

RECRUITING

Novartis Investigative Site, Erlangen

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

94800

RECRUITING

Novartis Investigative Site, Villejuif

168583

RECRUITING

Novartis Investigative Site, Singapore

300308

RECRUITING

Novartis Investigative Site, Tianjin

510060

RECRUITING

Novartis Investigative Site, Guangzhou

M4N 3M5

RECRUITING

Novartis Investigative Site, Toronto

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

2625 AD

RECRUITING

Novartis Investigative Site, Delft

4200-072

RECRUITING

Novartis Investigative Site, Porto

03080

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

08907

RECRUITING

Novartis Investigative Site, L'Hospitalet de Llobregat

08036

RECRUITING

Novartis Investigative Site, Barcelona

W12 0HS

RECRUITING

Novartis Investigative Site, London

S10 2SJ

RECRUITING

Novartis Investigative Site, Sheffield

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY