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CDK4/6 Inhibitor

Copanlisib + Usual Treatment for Advanced Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Cynthia X Ma
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Washout from prior systemic anti-cancer therapy of at least 3 weeks from chemotherapy or 5 half-lives from oral targeted drugs, and treatment related adverse events recovered to grade 1 (except for alopecia) before the start of study treatment. Washout from prior radiation therapy of at least 2 weeks before the start of the study treatment. Washout from prior endocrine therapy is not required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the effects of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative stage IV breast cancer.

Who is the study for?
This trial is for adults with hormone receptor positive, HER2 negative metastatic breast cancer. Participants must have recovered from previous treatments and agree to use contraception. They should not have had more than one chemotherapy in the metastatic setting or certain prior medications, and they can't join if they've had recent major surgeries, uncontrolled illnesses, or are pregnant.Check my eligibility
What is being tested?
The study tests adding copanlisib to fulvestrant and abemaciclib (usual therapy) for advanced breast cancer. It's a phase I/II trial aiming to see if this combination works better than the usual therapy alone by blocking enzymes that help tumor cells grow.See study design
What are the potential side effects?
Potential side effects include blood disorders, high blood sugar levels, fatigue, digestive issues like diarrhea or liver problems. There may also be risks of infection due to lowered immune function and possible heart-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have not had cancer treatment for 3 weeks or the required time for my medication.
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My breast cancer is ER/PR positive, HER2 negative, and stage IV.
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My kidney function, measured by GFR, is at least 30 mL/min.
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I can take care of myself but might not be able to do heavy physical work.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B virus load is undetectable with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity (DLT) (Phase I)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Change in tumor pAKT levels
Clinical benefit rate
Effectiveness of fulvestrant, abemaciclib, and copanlisib (FAC) compared to fulvestrant and abemaciclib (FA)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase II, Arm I (FAC) (copanlisib, abemaciclib, fulvestrant)Experimental Treatment8 Interventions
Patients receive copanlisib hydrochloride as in phase I. Patients also receive abemaciclib PO BID on days 1-28 and fulvestrant IM on days 1 and 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an ECHO or MUGA scan during screening. Patients also undergo blood sample collection pre-treatment, cycle 1 days 1, 8, 15, and 22, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, and then every 3 cycles thereafter and at time of progression. Patients undergo tissue biopsy pre-treatment and optionally on cycle 1 day 15 and at the time of progression. Patients also undergo imaging at screening and at the completion of cycle 3, then every 3 cycles thereafter.
Group II: Phase I Part B (copanlisib, abemaciclib, fulvestrant)Experimental Treatment8 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 or days 1 and 15 (depending on dose level) and abemaciclib PO twice daily BID for 5 days each week (2 days off). Patients also receive fulvestrant IM on days 2 and 16 of cycle 1, and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an ECHO or MUGA scan during screening. Patients also undergo blood sample collection pre-treatment, cycle 1 days 1, 8, 15, and 22, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, and then every 3 cycles thereafter and at time of progression. Patients undergo tissue biopsy pre-treatment and optionally on cycle 1 day 15 and at the time of progression. Patients also undergo imaging at screening and at the completion of cycle 3, then every 3 cycles thereafter.
Group III: Phase I Part A (copanlisib, abemaciclib, fulvestrant)Experimental Treatment8 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 or days 1 and 15 (depending on dose level) and abemaciclib PO BID on days 2-28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive fulvestrant IM on days 2 and 16 of cycle 1, and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an ECHO or MUGA scan during screening. Patients also undergo blood sample collection pre-treatment, cycle 1 days 1, 8, 15, and 22, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, and then every 3 cycles thereafter and at time of progression. Patients undergo tissue biopsy pre-treatment and optionally on cycle 1 day 15 and at the time of progression. Patients also undergo imaging at screening and at the completion of cycle 3, then every 3 cycles thereafter.
Group IV: Phase II, Arm II (FA) (abemaciclib, fulvestrant)Active Control7 Interventions
Patients receive abemaciclib PO BID on days 1-28 and fulvestrant IM on days 1 and 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an ECHO or MUGA scan during screening and ECG during screening and as clinically indicated. Patients undergo an ECHO or MUGA scan during screening. Patients also undergo blood sample collection pre-treatment, cycle 1 days 1, 8, 15, and 22, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, and then every 3 cycles thereafter and at time of progression. Patients undergo tissue biopsy pre-treatment and optionally on cycle 1 day 15 and at the time of progression. Patients also undergo imaging at screening and at the completion of cycle 3, then every 3 cycles thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Echocardiography
2013
Completed Phase 4
~11670
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Abemaciclib
2019
Completed Phase 2
~1710
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,340 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Cynthia X MaPrincipal InvestigatorYale University Cancer Center LAO
~5 spots leftby Jun 2025
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