Copanlisib for Breast Cancer
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
See full descriptionAbout the trial for Breast Cancer
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.
About The Treatment
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.