Clinical trial • Phase I/II • Oncology
ATIRMOCICLIB for Metastatic breast cancer | Triple-negative breast cancer | Hormone receptor-positive breast cancer | HER2-positive breast cancer | HER2-low breast cancer
Phase I/II trial of ATIRMOCICLIB for Metastatic breast cancer | Triple-negative breast cancer | Hormone receptor-positive breast cancer | HER2-positive br…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic breast cancer | Triple-negative breast cancer | Hormone receptor-positive breast cancer | HER2-positive breast cancer | HER2-low breast cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule | Monoclonal antibody | ADC
Key dates
- Initial CTIS Submission Date
- 02-05-2024
- First CTIS Authorization Date
- 13-06-2024
Trial design
Randomised, open-label, atezolizumab + nab-paclitaxel (control arm indicated by document titles such as 'atezo_nab_pac control icf'); dosing and schedule not specified in the available json Phase I/II trial in France, Germany, Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Atezolizumab + nab-paclitaxel (control arm indicated by document titles such as 'Atezo_Nab_Pac Control ICF'); dosing and schedule not specified in the available JSON
- Target Sample Size
- 269
Eligibility
Recruits 269 Vulnerable population selected (isVulnerablePopulationSelected: true). Multiple subject information and informed consent forms present (including country-specific ICFs and a document titled 'L1_CO40115_SIS and ICF_Infant Authorization_Sanitized'), indicating specific consent/authorization documents for infants/vulnerable groups are provided; explicit assent procedures are not described in the available JSON..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Multiple subject information and informed consent forms present (including country-specific ICFs and a document titled 'L1_CO40115_SIS and ICF_Infant Authorization_Sanitized'), indicating specific consent/authorization documents for infants/vulnerable groups are provided; explicit assent procedures are not described in the available JSON.
Inclusion criteria
- {"criterion_text":"- Age >/= 18 years at the time of signing Informed Consent Form"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1"}
- {"criterion_text":"- Metastatic or inoperable locally advanced breast cancer"}
- {"criterion_text":"- Measurable disease (at least one target lesion) according to RECIST v1.1 (or, for Cohort 5 only, evaluable bone disease) For Cohort 5, patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation."}
- {"criterion_text":"- Life expectancy >/= 3 months, as determined by the investigator"}
- {"criterion_text":"- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment"}
Exclusion criteria
- {"criterion_text":"- Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 or better with the exception of alopecia of any grade and Grade </= 2 peripheral neuropathy"}
- {"criterion_text":"- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)"}
- {"criterion_text":"- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases"}
- {"criterion_text":"- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted"}
- {"criterion_text":"- Significant cardiovascular disease"}
- {"criterion_text":"- History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death Bilateral breast cancer is allowed if both cancers meet the inclusion criteria or the phenotypically different breast cancer meets the exception of more than 2 years prior to screening and negligible risk of metastasis or death at time of screening"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Stage 1 1. ORR","definition_or_measurement_approach":"Objective response rate (ORR). Efficacy assessments per RECIST v1.1 (measurable disease criteria described in inclusion)."}
- {"endpoint_text":"- Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0","definition_or_measurement_approach":"Adverse events and laboratory abnormalities graded using NCI CTCAE v4.0; incidence, nature and severity recorded."}
- {"endpoint_text":"- Stage 1 and 2 2. Change from baseline in vital signs and ECG parameters","definition_or_measurement_approach":"Change from baseline measurements in vital signs and ECG parameters recorded at scheduled visits."}
- {"endpoint_text":"- Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in pre-specified clinical laboratory tests; timing and specific tests per protocol."}
Secondary endpoints
- {"endpoint_text":"- Stage 1 1. PFS","definition_or_measurement_approach":"Progression-free survival (PFS); likely per RECIST v1.1 (not explicitly restated in endpoint list)."}
- {"endpoint_text":"- Stage 1 2. DCR","definition_or_measurement_approach":"Disease control rate (DCR); standard definition (CR+PR+SD) per protocol (RECIST v1.1 referenced elsewhere)."}
- {"endpoint_text":"- Stage 1 3. OS","definition_or_measurement_approach":"Overall survival (OS): time from randomization/enrollment to death from any cause."}
- {"endpoint_text":"- Stage 1 4. DOR","definition_or_measurement_approach":"Duration of response (DOR): time from first documented response to progression or death."}
- {"endpoint_text":"- Stage 1 5. OS at specific timepoints","definition_or_measurement_approach":"Overall survival at pre-specified timepoints (specific timepoints not listed in JSON)."}
Recruitment
- Planned Sample Size
- 269
- Recruitment Window Months
- 98
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms (multiple country- and arm-specific ICF documents listed). Country-specific ICFs and translations present (examples: DE, ES, FR documents and multiple 'L1' ICF variants). An 'Infant Authorization' document is listed; explicit age-specific assent procedures are not described in the JSON.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 56
France
- Earliest CTIS Part Ii Submission Date
- 29-05-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 671
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Contact Person Name
- Olivier Tredan
- Contact Person Email
- olivier.tredan@lyon.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Contact Person Name
- Joana Mourato Ribeiro
- Contact Person Email
- joana-mourato.ribeiro@gustaveroussy.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Oncology
- Contact Person Name
- Florence Dalenc
- Contact Person Email
- dalenc.florence@iuct-oncopole.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 29-05-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 673
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Contact Person Name
- Peter Fasching
- Contact Person Email
- peter.fasching.studien@uk-erlangen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Contact Person Name
- Anja Welt
- Contact Person Email
- anja.welt@uk-essen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 29-05-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 677
- Number Of Sites
- 6
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Maria Martinez Garcia
- Contact Person Email
- MariaMartinezGarcia@parcdesalutmar.cat
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Contact Person Name
- Luis de la Cruz Meriono
- Contact Person Email
- ldelacruzmerino@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Maria Gion Cortes
- Contact Person Email
- maria.gion@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Ana Mafalda Antunes Melo Oliveira
- Contact Person Email
- moliveira@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro (duplicate entry resolved)
- Department Name
- Oncology
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Global CRO
Third parties
- {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Seagen Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Atrys Health S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- RO7881583
- Active Substance
- ATIRMOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Investigational Product Name
- EMPAGLIFLOZIN
- Active Substance
- EMPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- Fulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 250 mg
- Investigational Product Name
- SACITUZUMAB GOVITECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Investigational Product Name
- Verzenios 100 mg film-coated tablets
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Investigational Product Name
- Verzenios 50 mg film-coated tablets
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 50 mg
- Investigational Product Name
- Faslodex 250 mg solution for injection
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 250 mg
- Investigational Product Name
- INAVOLISIB
- Active Substance
- INAVOLISIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Starting Dose
- 1200 mg (product strength listed)
- Investigational Product Name
- LETROZOLE ACCORD HEALTHCARE 2,5 mg, comprimé pelliculé
- Active Substance
- LETROZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 2.5 mg
- Investigational Product Name
- PALBOCICLIB
- Active Substance
- PALBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- RoActemra 20 mg/mL concentrate for solution for infusion
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg/mL formulation listed
- Investigational Product Name
- Kisqali 200 mg film-coated tablets
- Active Substance
- RIBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 200 mg
- Investigational Product Name
- Abraxane 5 mg/ml powder for dispersion for infusion
- Active Substance
- PACLITAXEL ALBUMIN-BOUND
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Investigational Product Name
- METFORMIN
- Active Substance
- METFORMIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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