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PI3K inhibitor

Copanlisib for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Elizabeth C Dees
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post treatment
Awards & highlights

Summary

This phase I/II trial studies the side effects and how well copanlisib works when given together with fulvestrant in treating patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has spread to other places in the body (advanced) and progressing after prior treatment. HER2 and ER are two types of proteins called receptors that can affect the growth of breast cancer cells. Additionally, investigators hope to learn from this study if tumor genetic information is important for predicting whether this type of breast cancer will respond to fulvestrant and copanlisib. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving copanlisib and fulvestrant may work better in treating patients with ER+ and HER2- breast cancer compared to fulvestrant alone.

Eligible Conditions
  • Breast Cancer
  • Brain Metastasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicity (DLT)
Secondary study objectives
Incidence of adverse events
Progression-free survival (PFS)
Response rate
Other study objectives
Biomarkers analysis
Pharmacokinetics (PK) and pharmacodynamic data (RPPA)

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590
75%
Platelet count decreased
75%
Lymphocyte count decreased
71%
Fatigue
71%
White blood cell decreased
67%
Anemia
67%
Neutrophil count decreased
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Anorexia
46%
Diarrhea
46%
Lipase increased
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hypotension
25%
Hyperkalemia
25%
Weight loss
25%
Dehydration
25%
Vomiting
25%
Constipation
25%
Rash maculo-papular
21%
Edema limbs
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
17%
Chills
17%
Thromboembolic event
17%
Pain
17%
Alkaline phosphatase increased
17%
Creatinine increased
17%
Sinus tachycardia
17%
Dizziness
13%
Dyspnea
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
13%
Anxiety
13%
Tinnitus
8%
Ascites
8%
Cough
8%
Hypoxia
8%
Neck pain
8%
Gallbladder obstruction
8%
Back pain
8%
Insomnia
8%
Pleural effusion
8%
Bloating
8%
General disorders and administration site conditions -Other
8%
Abdominal distension
8%
Dysphagia
8%
Pruritus
8%
Rash acneiform
8%
Peripheral sensory neuropathy
8%
Infections and infestations - Other
8%
Dysgeusia
8%
Depression
4%
Colitis
4%
Dry mouth
4%
Pancreatitis
4%
Toothache
4%
Hypercalcemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Nasal congestion
4%
Bone pain
4%
Paroxysmal atrial tachycardia
4%
Ear pain
4%
Cholecystitis
4%
Fracture
4%
Allergic reaction
4%
Neoplasms benign, malignant and unspecified - Other
4%
Gastrointestinal disorders -Other
4%
Stomach pain
4%
Blood antidiuretic hormone abnormal
4%
Acute kidney injury
4%
Gait disturbance
4%
Activated partial thromboplastin time prolonged
4%
Urine output decreased
4%
Postnasal drip
4%
Productive cough
4%
Sore throat
4%
Hypernatremia
4%
Hyperuricemia
4%
Confusion
4%
Pneumonitis
4%
Pericarditis
4%
Cataract
4%
Dry eye
4%
Injury, poisoning and procedural complications - Other
4%
Venous injury
4%
Infusion site extravasation
4%
Colonic obstruction
4%
Investigations - Other
4%
Phlebitis
4%
Wheezing
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Hoarseness
4%
Hepatic infection
4%
Infections and Infestations - Other
4%
Urinary tract obstruction
4%
Lung infection
4%
Gastroesophageal reflux disease
4%
Malaise
4%
Musculoskeletal and connective tissue disorders - Other
4%
Skin ulceration
4%
Headache
4%
Parathesia
4%
Gallbladder infection
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Sinus bradycardia
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib, fulvestrant)Experimental Treatment2 Interventions
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 and fulvestrant IM over 1-2 minutes on days 1 and 15 of cycle 1 and on day 1 beginning cycle 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,841 Previous Clinical Trials
41,002,815 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Elizabeth C DeesPrincipal InvestigatorDuke University - Duke Cancer Institute LAO
~0 spots leftby Sep 2025
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