CLINICAL TRIAL

Copanlisib for Breast Cancer

Recruiting · 18+ · All Sexes · Los Angeles, CA

This study is evaluating the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage IV breast cancer

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About the trial for Breast Cancer

Eligible Conditions
Anatomic Stage IV Breast Cancer AJCC v8 · Carcinoma · Metastatic Breast Carcinoma · Breast Neoplasms · HER2-Positive Breast Carcinoma

Treatment Groups

This trial involves 2 different treatments. Copanlisib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Copanlisib
DRUG
Trastuzumab
BIOLOGICAL
Pertuzumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Trastuzumab
BIOLOGICAL
Pertuzumab
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
FDA approved
Trastuzumab
FDA approved
Pertuzumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Phase 1B: Any prior number of lines of therapy in metastatic setting is allowed, provided patients are considered candidates for trastuzumab and pertuzumab combination or on maintenance trastuzumab and pertuzumab (with or without prior chemotherapy) as long as dose limiting toxicity (DLT) can be determined. For Phase 2:Patients should have only received first line of induction chemotherapy (taxane) with trastuzumab and pertuzumab in the metastatic setting
For Phase 2-Patients must be within 8 weeks of completion of first-line induction chemotherapy (i.e., 4-8 cycles of any taxane, trastuzumab and pertuzumab) without evidence of progression. Patients may receive up to 2 doses of HER2 targeted treatment between end of induction treatment and start of trial, while eligibility is being confirmed
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 9 g/dL
You have a pathogenic mutation in either PIK3CA or PTEN on molecular testing. show original
Clinical stage IV as assessed by American Joint Committee on Cancer (AJCC) (8th edition, anatomic staging) guidelines with known metastatic disease (Edge and Compton, 2010; Amin et al. show original
HER2+ breast cancer patients with any ER/PR status as assessed by the American Society of Clinical Oncology (ASCO)-College of American Pathologists (ASCO-CAP) guidelines (Wolff et al. show original
You have a left ventricular ejection fraction (LVEF) of 50% or more. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Copanlisib will improve 3 primary outcomes, 4 secondary outcomes, and 5 other outcomes in patients with Breast Cancer. Measurement will happen over the course of From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 months.

Progression-free survival (PFS) (Phase II)
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST, ASSESSED UP TO 3 MONTHS
The statistical test for the primary analysis will be the partial likelihood ratio test of a stratified Cox PH model with treatment group as a covariate.
PFS (Phase Ib)
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST, ASSESSED UP TO 3 MONTHS
Change in expression of pharmacodynamics markers downstream of PI3K inhibition (Phase II)
BASELINE UP TO 3 MONTHS
Will correlate PFS and OS with change in expression of pharmacodynamics markers downstream of PI3K inhibition.
Change in expression of genes involved in alternate signaling pathways identified through reverse phase protein array (RPPA) (Phase II)
BASELINE UP TO 3 MONTHS
Will correlate PFS and OS with change in expression of genes involved in alternate signaling pathways identified through RPPA.
Hormone receptor (HR) status (estrogen receptor [ER] and progesterone receptor [PR]) (Phase II)
UP TO 3 MONTHS
Will correlate PFS and OS with hormone receptor status (ER and PR). Will assess the extent to which treatment effects (measured as hazard ratio for time to progression and odds ratio for response) depend on HR status (using product terms in logistic and Cox PH regression models).
Incidence of adverse events and serious adverse events (Phase Ib)
UP TO 3 MONTHS
The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event (AE) reporting.
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Patient Q & A Section

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

How many people get breast cancer a year in the United States?

The number of new breast cancers diagnosed a year in the United States is about 1.8 million, an increase of 7.7% between 2004 and 2014.

Anonymous Patient Answer

What is breast cancer?

The [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is the most common type of cancer and is the sixth leading cause of cancer related deaths among women in the UK. About one in 8 women in the UK will develop breast cancer in their lifetime. The risk of developing breast cancer increases progressively with age. A lifetime risk of 1–4% would make it the 1st most common cancer in the UK.

Anonymous Patient Answer

What are common treatments for breast cancer?

All patients with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) may require surgery, chemotherapy and/or radiation therapy. In case of local tumor involvement of breast and axillary lymph nodes, surgery of breast and axillary lymph nodes or axillary dissection is recommended. There are a large number of adjuvant therapies available depending at which pathological cancer stages they are used for and patient's prognostic indicators.

Anonymous Patient Answer

What causes breast cancer?

The exact cause is unknown, but it is known to be due to an accumulation of genetic defects that may be caused by environmental factors. A risk of breast cancer may be increased if an individual have a family history of breast cancer.

Anonymous Patient Answer

What are the signs of breast cancer?

Most of the signs are not suggestive of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and in fact the signs are commonly found in non-cancerous states. Breast cancer should always be ruled out if suspected. Clinicians should have a high degree of suspicion and take a complete history from the patients with breast tumors.

Anonymous Patient Answer

Can breast cancer be cured?

Breast cancer cells usually are highly resistant to cytotoxic drugs, but the cancer cells of a small percentage of breast cancers become drug sensitive and kill the tumor cells. Breast cancer treatments cannot be considered 'curative' if this drug resistant subgroup of cancer cells is not removed from the cancer population. For the chemotherapy regimen used in breast cancer treatment to consider cure, the complete and unopposed eradication of these drug resistant tumor cells is required.

Anonymous Patient Answer

What are the chances of developing breast cancer?

Of the risk factors for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) some are common also for colorectal cancer, and some are uncommon; nevertheless they might be significant. The best chance of developing colorectal cancer is associated with age. Other risk factors that modify the risk for both cancers are: sex, ethnicity, obesity, type of diet, and smoking\n

Anonymous Patient Answer

What is copanlisib?

Copanlisib is a novel Bcr-Abl inhibitor and a potent inducer of apoptosis. A phase II study involving patients with relapsed or refractory multiple myeloma, leukemia and lymphomas, showed high response rate with manageable toxicity for patients with advanced solid tumors. Copanlisib (SND1417) is now in phase three development in patients with advanced solid tumors.\n\nAccording to the statistics there is around 12,834 people and 8,301 households residing in the city (2011). The population density of the city is 20.9 persons per hectare (2011). The total population of the city as of 2010 was 8,823.

Anonymous Patient Answer

What is the survival rate for breast cancer?

The current best available estimation of overall survival is 12.5 months, a survival rate of 68.4%. These long-term results were achieved in a cohort of patients with ER-positive, non-luminal, early-, node-, and HER-2-negative breast cancer, who had not received adjuvant therapy. The patient cohort consisted of younger women (average age of 55.6) diagnosed and treated in 2008–2009 in two metropolitan regions in central North America.

Anonymous Patient Answer

What are the latest developments in copanlisib for therapeutic use?

Copanlisib for malignant mesothelioma had limited activity as single agent in clinical trials. As monotherapy, this molecule is not recommended for the metastatic setting, where it is not likely to lead to survival benefit in this scenario.

Anonymous Patient Answer

What are the common side effects of copanlisib?

In the clinical trial, common adverse events reported by patients in treatment with 25 or 50 mg every four weeks of the investigational compound Copanlisib are fatigue, cough, headache, decreased appetite, and decreased weight. None of these adverse events was considered clinically significant based on frequency or severity and were unlikely to justify discontinuation. No deaths occurred in the clinical trial.

Anonymous Patient Answer

Does breast cancer run in families?

In a recent study, findings suggest that breast cancer does run in families, but are inconclusive regarding the genetic basis of an association with age of breast cancer onset.

Anonymous Patient Answer
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