Please assess the completion status of the following clinical trial:

Trial Title: Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Post-menopausal (if female) defined as: 1) prior bilateral oophorectomy, 2) age 60 or over, or 3) \< 60 years and amenorrheic for at least 12 months with follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range per institutional parameters); use of luteinizing hormone-releasing hormone (LHRH) agonists to induce chemical ovarian ablation will not be allowed for this study~* Tumor is hormone receptor (HR)+ (estrogen receptor and/or progesterone receptor positive with at least 10% expression of either receptor by local immunohistochemical staining) and HER2 negative based on local assessment~* FOR PHASE Ib PORTION OF THE STUDY:~* Locally advanced/non-operable or metastatic breast cancer that has not been previously treated in the metastatic setting with systemic therapy (i.e. first line treatment)~* Measurable disease per RECIST 1.1~* FOR PHASE II PORTION OF THE STUDY:~* Clinical stage I (breast tumor \>= 1.0 cm in diameter), stage II or stage III breast cancer (according to the American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th Edition, 2010); multifocal disease is allowed if confined to 1 breast, as long as one tumor is at least 1 cm and meets all of the other inclusion criteria~* Breast cancer suitable for mandatory baseline core biopsy~* No prior systemic therapy or radiotherapy for currently-diagnosed invasive or noninvasive breast cancer~* FOR ALL PHASES (Ib AND II):~* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L~* Platelets \> 100 x 10\^9/L~* Hemoglobin \>= 8 g/dL (phase Ib) or \>= 10 g/dL (for phase II portion)~  * For phase Ib portion only: patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day of the erythrocyte transfusion~* Bilirubin =\< 1.5 times the upper limit of normal (ULN)~* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3.0 times ULN~* Subjects with Gilbert's syndrome, confirmed by genotyping or Invader UGTIA1 molecular assay prior to study entry, must have total bilirubin \< 3.0 times ULN~* Serum creatinine =\< 1.5 times ULN~* Lipase =\< 1.5 x ULN~* International normalized ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x ULN~* Left ventricular ejection fraction (LVEF) \>= 50%~* Eastern Cooperative Oncology Group (ECOG) performance status 0-1~Exclusion Criteria:~* FOR PHASE Ib ONLY:~* Early stage (curable) breast cancer~* FOR PHASE II ONLY:~* Metastatic breast cancer (local spread to axillary or internal mammary lymph nodes is permitted)~* Prior systemic therapy for invasive or non-invasive (DCIS) breast cancer~* Prior radiotherapy to the ipsilateral chest wall or breast for any malignancy~* Bilateral invasive breast cancer~* FOR ALL PHASES (Ib AND II): Inflammatory breast cancer~* FOR ALL PHASES (Ib AND II): Concurrent therapy with any other non-protocol anti-cancer therapy~* FOR ALL PHASES (Ib AND II): History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix~* FOR ALL PHASES (Ib AND II): Concurrent diagnosis of pheochromocytoma~* FOR ALL PHASES (Ib AND II): Current therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer; subjects must have discontinued therapies for at least 28 days prior to first baseline biopsy~* FOR ALL PHASES (Ib AND II): Concurrent treatment with postmenopausal hormone replacement therapy; prior treatment must be stopped for at least 28 days prior to first baseline biopsy~* FOR ALL PHASES (Ib AND II): Type I diabetes or patients on insulin therapy are not allowed; uncontrolled type II diabetes not allowed (glycosylated hemoglobin \[HbA1c\] \> 7.5)~* FOR ALL PHASES (Ib AND II): Proteinuria of \>= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 as estimated by urine protein : creatinine ratio \> 3.5 on a random urine sample~* FOR ALL PHASES (Ib AND II): Uncontrolled arterial hypertension despite optimal medical management~* FOR ALL PHASES (Ib AND II): Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel~* FOR ALL PHASES (Ib AND II): Known history of human immunodeficiency virus (HIV) infection~* FOR ALL PHASES (Ib AND II): Uncontrolled infection; active, clinically serious infections (\> CTCAE grade 2)~* FOR ALL PHASES (Ib AND II): History of significant cardiac disease:~  * Congestive heart failure \> New York Heart Association (NYHA) class 2~ * Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)~ * Myocardial infarction less than 6 months before start of test drug~ * Anti-arrhythmic therapy (beta blockers or digoxin are permitted)~* FOR ALL PHASES (Ib AND II): Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication~* FOR ALL PHASES (Ib AND II): Participants receiving anticoagulation therapy are not allowed~* FOR ALL PHASES (Ib AND II): Patients with evidence or history of bleeding diathesis; any hemorrhage or bleeding event \>= CTCAE grade 3 within 4 weeks of start of study medication~* FOR ALL PHASES (Ib AND II): Blood or platelet transfusion within 7 days prior to treatment start~* FOR ALL PHASES (Ib AND II): Non-healing wound or ulcer~* FOR ALL PHASES (Ib AND II): History of, or current autoimmune disease~* FOR ALL PHASES (Ib AND II): Major surgical procedure or significant traumatic injury (as judged by the investigator) within 28 days before start of study medication, open biopsy within 7 days before start of study medication~* FOR ALL PHASES (Ib AND II): Patients with seizure disorder requiring medication~* FOR ALL PHASES (Ib AND II): Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation~* FOR ALL PHASES (Ib AND II): Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids; previous corticosteroid therapy must be stopped or reduced to the allowed dose at least 7 days prior to the first study drug administration; if a patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated to the maximum allowed dose after the patient has signed the consent document~* FOR ALL PHASES (Ib AND II): History of having received an allogeneic bone marrow or organ transplant~* FOR ALL PHASES (Ib AND II): Chronic oxygen therapy

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arm A (copanlisib, letrozole) (Type: EXPERIMENTAL): PHASE II: Patients receive copanlisib (MTD) IV over 1 hour on days 1, 8, and 15 and letrozole PO continuously on days 1-28. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression, or unacceptable toxicity.
- Arm B (copanlisib, palbociclib, letrozole) (Type: EXPERIMENTAL): PHASE II: Patients receive copanlisib (MTD) IV over 1 hour on days 1, 8, and 15, palbociclib PO QD on days 1-21, and letrozole PO continuously on days 1-28. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm C (copanlisib, palbociclib, letrozole) (Type: EXPERIMENTAL): PHASE II: Patients receive palbociclib PO QD for days 1-14 of course 1 and letrozole PO continuously on days 1-14. Patients then undergo biopsy. Patients then receive copanlisib IV over 1 hour on days 1, 8, and 15 and letrozole PO continuously on days 1-28. Treatment with copanlisib (MTD) and letrozole repeats every 28 days for up to 3.5 courses in the absence of disease progression or unacceptable toxicity.
- Phase Ib (copanlisib, palbociclib, letrozole) (Type: EXPERIMENTAL): PHASE Ib: Patients with metastatic breast cancer receive copanlisib IV over 1 hour on days 1, 8, and 15, palbociclib PO QD on days 1-21, and letrozole PO continuously on days 1-28. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: enrollment issues