Clinical Trials List
Protocol NumberCO40115
NCT Number(ClinicalTrials.gov Identfier)NCT03424005
Active
2025-06-30 - 2028-12-31
Others
Not yet recruiting2
ICD-10C50.011
Malignant neoplasm of nipple and areola, right female breast
ICD-10C50.012
Malignant neoplasm of nipple and areola, left female breast
ICD-10C50.019
Malignant neoplasm of nipple and areola, unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
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)
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Metastatic Breast Cancer
Objectives
The aim of this trial was to evaluate the efficacy, safety, and pharmacokinetics of this combination therapy in patients with metastatic breast cancer. We sought to understand the positive and negative effects of this treatment on the subjects and on their hormone receptor-positive breast cancer.
Test Drug
Film-coated tablets
Film-coated tablets
Pre-filled injection
Film-coated tablets
Film-coated tablets
Film-coated tablets
Pre-filled injection
Film-coated tablets
Film-coated tablets
Active Ingredient
Inavolisib
abemaciclib
fulvestrant
ribociclib
letrozole
abemaciclib
fulvestrant
ribociclib
letrozole
Dosage Form
116
116
230
116
116
116
230
116
116
Dosage
3mg & 9mg
50mg, 100mg, 150mg
250mg/5ml
200mg
2.5mg
50mg, 100mg, 150mg
250mg/5ml
200mg
2.5mg
Endpoints
Primary Efficacy Goal
Phase 1
• Assess the efficacy of concomitant therapy during Phase 1
-ORR, defined as the proportion of patients who achieved a complete or partial response ≥ 4 weeks after two consecutive responses, as determined by the trial administrator according to RECIST v1.1.
Phase 1
• Assess the efficacy of concomitant therapy during Phase 1
-ORR, defined as the proportion of patients who achieved a complete or partial response ≥ 4 weeks after two consecutive responses, as determined by the trial administrator according to RECIST v1.1.
Inclution Criteria
Inclusion Criteria
Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
Age >/= 18 years at the time of signing Informed Consent Form
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Able to comply with the study protocol, in the investigator's judgment
Metastatic or inoperable locally advanced breast cancer
Measurable disease (at least one target lesion) according to RECIST v1.1
Life expectancy >/= 3 months, as determined by the investigator
Tumor accessible for biopsy, unless archival tissue is available
Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
Age >/= 18 years at the time of signing Informed Consent Form
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Able to comply with the study protocol, in the investigator's judgment
Metastatic or inoperable locally advanced breast cancer
Measurable disease (at least one target lesion) according to RECIST v1.1
Life expectancy >/= 3 months, as determined by the investigator
Tumor accessible for biopsy, unless archival tissue is available
Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Exclusion Criteria
Exclusion Criteria
Exclusion Criteria for Stage 1
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Eligibility only for the control arm
Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)
Adverse events from prior anti-cancer therapy that have not resolved to Grade Treatment with investigational therapy within 28 days prior to initiation of study treatment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
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.
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation
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
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Exclusion Criteria for Stage 1
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Eligibility only for the control arm
Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)
Adverse events from prior anti-cancer therapy that have not resolved to Grade Treatment with investigational therapy within 28 days prior to initiation of study treatment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
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.
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation
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
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
The Estimated Number of Participants
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Taiwan
20 participants
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Global
580 participants
