The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
During pregnancy, a baby's heart rate can tell us a lot about how their brain and body develop. Our team is testing a new, easy-to-use device that you can wear at home to track the baby's heartbeat for up to 24 hours. By using the monitor in your everyday environment, we can learn more about your baby's development in a natural setting,…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study to better understand experiences related to extreme heat during pregnancy and to inform the development of heat preparedness resources for perinatal care. We are recruiting English-speaking participants who are 18 years of age or older and reside in New York State and…
We are conducting a research trial to determine if low dose Aspirin either 81 or 162 mg will prevent preterm birth in patients who have had a previous preterm birth, still birth, or complications of pregnancy including preeclampsia, small for gestational age baby, fetal growth restriction, or placental abruption. You will be randomized to 81 or 162 mg and…
You are invited to participate in a research study to understand how environmental exposures during pregnancy influence the health and development of children. This study will begin at pregnancy and follow your child through age 11. A trained research worker will work with you and your child, administering questionnaires to you and developmental evaluations…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study of stress and sleep in childhood and pregnancy, which will take place over the next year. We are recruiting pregnant people who identify as Latinx/Hispanic. You will be compensated for your time! We are flexible in scheduling convenient times for you to come in. The…
Pancreatic cancer is a deadly disease and the best hope for improving the chances of survival is to find it early. Some patients, called "high risk", have an inherited predisposition to pancreatic cancer. Certain medical centers have started programs where "high risk patients" undergo testing, such as receiving imaging scans, to look for…
Our team is looking at the relationship between a mother and her baby to see how different prenatal and infant experiences affect a baby's brain development. Specifically, we are looking at maternal immune activation (MIA) and how prenatal exposure to MIA can affect a baby's development. For our study, we ask participants to come in for up to 3…
The Center for Intergenerational Psychiatry at Columbia University is recruiting pregnant individuals. We want to learn how feeling worried or anxious (or not having these feelings) may impact pregnant individuals and their babies. We would like to invite people from a wide-range backgrounds who are in between 12 to 34 weeks of their pregnancy to…
We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
This research study is being done to understand how CPAP for sleep apnea may affect hypertensive disorders of pregnancy and other complications of pregnancy such as gestational diabetes. The purpose of the home sleep test is to find women with sleep apnea. Sleep apnea is when you have one or more pauses in breathing or shallow breaths while you sleep.…
This study will enroll participants who did or did not receive a SARS-CoV-2 vaccine during their pregnancy and have a child who is now 18-30 months of age. In order to assess the long-term outcomes of the offspring of those who received SARS-CoV-2 vaccine in pregnancy, a cohort study examining child developmental outcomes is needed. There are a number of…
Women will be enrolled at or prior to prenatal visit at 34-40 weeks gestation with follow-up visits within 48 hours of delivery, and 6 and 12 months postpartum among the mother and infant. Maternal and infant measurements will be conducted at each visit. The purpose of the study is to estimate cardiovascular disease risk in healthy and medically complicated…
Researchers at Columbia are looking at the changes that happen in the placenta when people become pregnant. Participation in this study involves a blood draw at three time points. Participants will be paid $50 at each time point. Participants who complete all three time points will receive bonus compensation.
Researchers at Columbia are looking into possible viral causes of stillbirth or late-term miscarriages in patients. We are looking for people who have recently had a late-term pregnancy loss (within the past week). Participation in this research involves a one-time blood draw. Participants will receive $50.
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
The Young, Empowered & Strong (YES) study is opened to women who were diagnosed with breast cancer between the ages of 15 and 39 years. Women will need to be within 3 years of the end of early active treatment (e.g. surgery, chemotherapy not including HER2-directed therapy, radiation), and have no know evidence of breast cancer recurrence. The study…
Are you currently pregnant or were you pregnant in the last 2 years? We want to hear from you! We are conducting interviews to understand how we can support physical and mental health during pregnancy and postpartum. Interviews will take place virtually over Zoom or via telephone and last about 60 minutes. There are also options to participate in person (…
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy…
The study is being done to answer the following question: How can we best help women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) and their healthcare providers make informed decisions about whether to take breast cancer risk-reducing pills (drugs to slow or prevent breast cancer from developing)? Participants in this study will learn…
The purpose of this study is to evaluate how safe and effective the NanoKnife System is at treating Stage 3 pancreatic adenocarcinoma. This is registry study and therefore, the NanoKnife System is not being used for study purposes. The safety and efficacy of this system will be evaluated by comparing survival rates, pain ratings, and number of adverse…
This study is being done to answer the following question: How does the combination of copanlisib and eribulin compare to eribulin alone to lengthen the time you can live with your metastatic triple-negative breast cancer without your cancer getting worse? We are doing this study because we want to find out if this approach is better or worse than the usual…
This study is being done to answer the following question: Can participants with HER2-positive breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after 12 weeks of chemotherapy and two HER-targeted therapies eliminate further chemotherapy after surgery? This would be a decrease in the total number of…
This study is being done to answer the following question: How can we best help patients and their clinicians make decisions about breast cancer treatment (surgery and other treatments, like radiation and chemotherapy)? We are doing this study because we want to better understand how to support patients in making decisions about breast cancer treatment. We…
The purpose of this study is to compare usual lymph node surgery to an added procedure during the surgery to help surgeons see the lymph node system better. During usual surgery, the lymph node system may be disrupted, which can cause swelling in the arm. This research study will use a new lymph node surgery technique to look at how fluid drains through the…
The purpose of this study is to examine whether removing some of the lymph nodes from the armpit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the armpit removed during breast surgery followed with radiation(standard of care). Patients will be randomized to either of…
This is a first-in-human, phase 1/1b, open-label study of single-agent PMD-026 conducted in participants with metastatic breast cancer. PMD-026 will initially be administered orally on a once-daily schedule. Part 1 of the study will evaluate PMD-026 in participants with metastatic breast cancer that have not responded to treatment, which may involve…
The purpose of this study is to assess the safety and effectiveness of giving anastrozole, palbociclib, trastuzumab, and pertuzumab to women with hormone receptor-positive, HER2-positive metastatic breast cancer. This combination of medications represents an all-biologic approach and avoids chemotherapy as first-line treatment of this disease.
The purpose of this study is to learn which treatment works best in patients with pancreatic cancer. The study explores multiple treatment combinations. A study drug called atezolizumab may be combined with other drugs such as cobimetinib, PEGPH20, and BL-8040. Patients may also be assigned to receive standard chemotherapy treatment.
The purpose of this study is to determine whether there is clinical benefit to continue therapy beyondprogression for metastatic or unresectable breast cancer. The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called Cyclin Dependent Kinase 4 and 6 inhibitors, which…
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
Paclitaxel is frequently used to treat breast cancer, but it can also cause neuropathy where the nerves of the hands and feet stop working properly. The symptoms of neuropathy can include pain, numbness, and difficulty with everyday activities like walking or typing. Paclitaxel-induced neuropathy is common and there are few treatment options. Our study will…
This research study involves receiving an experimental drug referred to as ZN-c5. This is the first study in humans using ZN-c5. The purpose of this research study is to test the safety of ZN-c5 at different dose levels. This study is designed to find out what effects, good and/or bad, ZN-c5 has on participants with breast cancer. Participants in both…
The purpose of this study is to identify if blood sugar elevations during chemotherapy may be related to the development of side effects from chemotherapy. This study will help us find out if blood sugar goes up during the course of chemotherapy, and if so, for the amount of time the blood sugar is elevated after a chemotherapy treatment. Results of this…
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse…
The purpose of this study is to compare any good and bad effects of using olaparib and atezolizumab in combination compared to olaparib alone. The use of olaparib alone or in combination with atezolizumab could shrink your cancer but could also cause side effects. This study will allow the researchers to know whether the combination approach is better, the…
This study examines diffuse optical tomography (DOT) as a way to monitor the progress of the breast cancer therapy. Specifically, it looks at DOTs ability to detect non-responders early in treatment and then adjust the therapy to improve response and overall survival. DOT is favorable to more conventional forms of cancer monitoring, such as physical exams,…
The purpose of this study is to determine the effect of different doses of ZN-c5 on levels of hormone (estrogen) receptors in breast cancer and how large that effect is for each dose level. The amount of reduction in hormone receptors may indicate that the drug is doing what it intends to do and how effective it is. The results will help define what an…
This research study is being conducted to see if a new treatment using a study drug called Olaparib given after platinum based chemotherapy treatments can reduce the risk of pancreatic cancer from growing back. Participants will receive either Olaparib or placebo (no contains active medication) and will stay on the research study for as long as they are not…
The purpose of this trial is to determine whether the study drug, CX-839, reduces tumor size in patients with metastatic triple negative breast cancer when it is used in combination with the standard breast cancer treatment. CX-839 blocks the activity of a certain molecule that is overproduced by some cancer cells.
The purpose of this study is to compare the effects, good and/or bad, of study drug cobimetinib and paclitaxel for patients with metastatic truple-negative breast cancer (mTNBC). In this study, you will receive either a combination of cobimetinib and paclitaxel or placebo (no active medication) and paclitaxel. The study will also evaluate what side effects…
The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only…
The purpose of this study is to identify the doses of spartalizumab (PDR001) with LAG525 in combination with either NIR178, capmatinib (INC280), MCS110 or canakinumab (ACZ885) that can be given safely. The study will also test how well spartalizumab (PDR001) with LAG525 in combination with either NIR178, capmatinib (INC280), MCS110 or canakinumab (ACZ885)…
This study is for women with breast cancer who will be undergoing lumbar puncture to evaluate for the presence of leptomeningeal metastasis, a complication in which the cancer spreads to the membranes (meninges) surrounding the brain and spinal cord. This condition is typically diagnosed by examining the cerebrospinal fluid obtained from the lumbar puncture…
The purpose of this study is to test the safety, tolerability, and the behavior of the drug in your body of an experimental study drug, DHES0815A. The goal is to determine a safe and tolerable dose in patients with cancer and to measure how the body processes the study drug at different dose levels.
The purpose of this study is to determine the effectiveness of the study drug, sacituzumab govitecan, to the treatment of physicians choice, in patients with metastatic, triple negative breast cancer.
The purpose of this study is to test whether GVAX pancreas vaccine and CRS-207 together are safe and work better than chemotherapy to treat individuals with advanced pancreatic cancer who have received at least one prior chemotherapy treatment for metastatic cancer. This study will also look at whether CRS-207 alone is safe and works better than…
The purpose of this study is to gather information on the safety of TH-302 and its effect on patients with HER2+ breast cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about this specific cancer such as the level of oxygen that is present. This may…
This is a cohort study looking at the effects of anastrozole (an aromatase inhibitor) on patients, and specifically at Aromatose Inhibitor Musculoskeletal Symptoms (AIMSS). The genetic predictors of AIMSS will also be evaluated. Participants will take daily anastrazole and will be followed for 12 months. The study will enroll 35 patients at Columbia…
This is a research study of cryotherapy (cold therapy) vs. compression therapy for the prevention of taxane-induced neuropathy. This study will assess the effect of a wearing frozen garments or compression garments on preventing neuropathy pain and discomfort that can be caused by taxane chemotherapy. Cryotherapy involves wearing frozen garments on both…
Some people who are treated for breast cancer develop swelling in their arms as a result of their treatment. This swelling is called lymphedema and it can be chronic. The purpose of this study is to see if early detection of arm swelling using a small painless device (called bioelectrical impedance), immediately followed by compression treatment, prevents…
This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing…
The purpose of this study is to capture and evaluate clinical data about the long-term safety and effectiveness of Novilasee - a FDA-cleared minimally invasive treatment for benign breast tumors in hopes that tracking and analyzing the safety and effectiveness of Novilase in a real world application will benefit future patients and the breast cancer…
The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. Metformin is a common treatment for patients with diabetes, and atorvastatin is a common therapy for elevated cholesterol. We will examine the effects of…
This study is for women who have been diagnosed with stage 2 or stage 3 breast cancer whose doctor has recommended that you receive radiation therapy after your mastectomy to prevent your breast cancer from coming back. Radiation uses particles of energy to kill any remaining cancer cells where your breast was removed or in the lymph nodes. Radiation after…
The main purpose of this study is to determine the safety and tolerability of Faslodex given directly into thebreast ducts of women with invasive breast cancer or Ductal Carcinoma In Situ (DCIS). This study is for women who have been diagnosed with invasive breast cancer or DCIS. DCIS is the presence of abnormal cells inside a milk duct in the breast, and…
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when…
This study involves research; it is the first time that MLN0128 will be studied in patients who are also receiving antihormonal medication. The main purposes of the study are to determine: The risks and discomforts of MLN0128 when given with antihormonal medication. Whether giving MLN0128 in combination with antihormonal medication affects the growthof your…
The purpose of this study is to determine whether the combination of study drugs Ruxolitinib plusTrastuzumab is safe and effective in stopping breast tumor growth in patients with HER2 positivemetastatic breast tumors who have already received Trastuzumab. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer.
This a Phase III study designed to compare the efficacy and the safety of the triplet combination of GDC-0077 plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of…
This is a study of patients delivering at Columbia University Medical Center-Allen Hospital. The investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also try to find out if there is a correlation between estimated blood loss and measured blood loss.
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in…
The purpose of this study is to determine the MTD of Ricolinostat (ACY-1215) in combination with weekly abraxane as well as evaluate the safety and tolerablility of Ricolinostat (ACY-1215) in combination with weekly abraxane.
The purpose of this study is to evaluate the effectiveness and safety of eribulin mesylate (eribulin) incombination with pembrolizumab in metastatic (spread of cancer from one part of body to another) triple-negative breast cancer (mTNBC).
The purpose of this study is to determine whether treatment with sacituzumab govitecan could provide a better response and improve survival (the amount of time you live without your cancer growing) than other forms of cancer treatment (either Eribulin, Capecitabine, Gemcitabine, Vinorelbine).
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to patients with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth. To find out which doses are safe, all…
The goal of this study is to determine if ribociclib in combination with letrozole as neoadjuvant endocrine therapy increases the proportion of women with PEPI score of 0 at surgery, compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy. The PEPI score measures the risk of breast cancer…
The purpose of this study is to see how safe investigational drug, LY2835219 is and how well it will work to help people with advanced hormone receptor (HR) positive, HER2 negative breast cancer. This study will investigate whether the combination of LY2835219 plus fulvestrant improves outcomes compared to fulvestrant alone for women with a certain type of…
The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without the subjects cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney…
The goal of the study is to determine whether coming to the hospital and having the labor started with medicine (i.e., labor induction) at 39 weeks of pregnancy can improve the baby's health at birth when compared with waiting for labor to start on its own.
To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.
The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions in Chinese patients. The Agendia Breast Cancer Suite includes MammaPrint, TargetPrint, BluePrint, and TheraPrint which are…
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low…
Tomography (DOT), can help predict how well patients respond to a pre-surgical therapy. This imaging technique uses light to create 3D maps of the blood, fat, and water content of the breast. Based on these measurements taken over 2 time points during therapy (before and after), we will try to determine if this new imaging technique can use early…
The purpose of this research study is to determine if the experimental drug balixafortide combined with eribulin is well tolerated and more effective for treating breast cancer compared with eribulin given alone. Balixafortide (POL6326) interacts with proteins called CXCR4 receptors which may directly suppress tumor growth through disruption of signaling…
The purpose of this study is to test the effect of a drug called retosiban on stopping preterm labor and delaying the birth of her baby. We will also study the safety of the drug to find out what effects; good or bad, retosiban has on women in preterm labor and their fetuses. A previous small study, involving 93 women with preterm labor, found that…
We are currently recruiting women to TMIST, a clinical trial that will help us develop strategies that tailor breast cancer screening to the risks of individual women. This is a screening trial. The purpose of this trial is to determine if tomosynthesis (3-D) mammography detects breast cancer at earlier stage than current method of 2-D digital mammography.
The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study…
The purpose of this research study is to determine if using a piece of the patient's residual tumor to develop a model of her cancer in mice that lack an immune system (also called an immune-deficient mouse) could help in determining which additional drugs or compounds to which an individual breast tumor is sensitive. The tumor implanted in the mouse…
The purpose of this study is to find out what side effects (unwanted effects) are caused in patients with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in…
This is a study for patients diagnosed with either breast cancer that is HER-2 positive, or breast cancer that is negative for estrogen, progesterone and HER-2 (triple-negative disease), and whose tumor can be removed by breast-conserving surgery. The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging)…