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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Echocardiography

2013

Completed Phase 4

~11670

Fulvestrant

2011

Completed Phase 3

~3690

Abemaciclib

2019

Completed Phase 2

~1710

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,643 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Cynthia X MaPrincipal InvestigatorYale University Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this research program recruited?

"Affirmative. Clinicaltrials.gov records suggest that this medical trial, initially posted on October 21st 2019 and most recently modified on November 9th 2022, is currently recruiting participants. 11 sites are collectively looking for 204 individuals to take part in the experiment."

Answered by AI

Are any opportunities available for volunteers to participate in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted on October 21st 2019 and is currently accepting applicants. 204 participants are being sought from 11 distinct locations."

Answered by AI

How many venues are currently administering this trial?

"Ohio State University Comprehensive Cancer Center in Columbus, Ohio, University of Kentucky/Markey Cancer Centre in Lexington, Kentucky and Wake Forest University Health Sciences in Winston-Salem North carolina are amongst the enrolment sites for this trial. Additionally there are 11 additional clinical centres participating."

Answered by AI

What conditions are typically managed with Fulvestrant?

"Fulvestrant can be prescribed to confront the effects of pi3k gene mutation, breast cancer and therapeutic procedures."

Answered by AI

What outcome is this clinical trial attempting to realize?

"The primary measure of success for this trial is the dose-limiting toxicity (DLT) over a five year period. Secondary metrics include median progression-free survival (PFS), overall survival, and PFS stratified by PIK3CA/PTEN status or tumor phosphorylated AKT levels. The RECIST 1.1 criteria will be used to measure overall survival while comparisons between both experimental arms will be conducted using log rank tests and Cox proportional hazard models with appropriate adjustments for patient characteristics."

Answered by AI

Have any other scientific inquiries been conducted into Fulvestrant?

"In 2004, Fulvestrant was first trialled at Lowell General Hospital. Since then 138 completed studies have been conducted and 233 are still active today, many of which originate from Columbus Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer

2020. "Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03939897.

All > Breast Cancer Anaheim > Metastatic Breast Cancer