FindTrial
Sign In

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503629-20-00
Acronym
CO40115
Enrollment
50
Registered
2024-06-13
Start date
2018-06-27
Completion date
Unknown
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC), hormone receptor positive breast cancer (HR+ BC), including triple negative breast cancer (TNBC), Metastatic breast cancer

Brief summary

Stage 1 1. ORR, Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters, Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results

Detailed description

Stage 1 1. PFS, Stage 1 2. DCR, Stage 1 3. OS, Stage 1 4. DOR, Stage 1 5. OS at specific timepoints

Interventions

DRUGINAVOLISIB
DRUGKisqali 200 mg film-coated tablets
DRUGVerzenios 50 mg film-coated tablets
DRUGFaslodex 250 mg solution for injection.
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGTecentriq
DRUGLetrozol STADA® 2
DRUG5 mg Filmtabletten
DRUGVerzenios 100 mg film-coated tablets
DRUGACTEMRA
DRUGVerzenios 150 mg film-coated tablets
DRUGSACITUZUMAB GOVITECAN
DRUGLETROZOLE ACCORD HEALTHCARE 2
DRUG5 mg
DRUGcomprimé pelliculé
DRUGFulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
DRUGFULVESTRANT ACCORD 250 mg
DRUGsolution injectable en seringue pré-remplie
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Stage 1 1. ORR, Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters, Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results—

Secondary

MeasureTime frame
Stage 1 1. PFS, Stage 1 2. DCR, Stage 1 3. OS, Stage 1 4. DOR, Stage 1 5. OS at specific timepoints—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026