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73 Breast Cancer Trials near Miami, FL
Power is an online platform that helps thousands of Breast Cancer patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerCDK4/6 Inhibitors for Metastatic Breast Cancer
Miami, Florida
The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.
The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.
Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:65+
Key Eligibility Criteria
Disqualifiers:Previous CDK4/6, Brain Metastases, Others
Must Be Taking:CDK4/6 Inhibitors
500 Participants Needed
Chemotherapy + Hormone Therapy for Breast Cancer
Miami Beach, Florida
This trial is testing if adding additional cancer-fighting drugs to treatments that stop certain body functions is better than just using the treatments that stop those functions alone. It targets younger women with early-stage breast cancer who have a higher risk of dying from the disease. The treatment works by stopping certain body functions and using drugs to kill cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 60
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Cardiac Disease, Others
Must Be Taking:Endocrine Therapy
3960 Participants Needed
Proton Therapy for Breast Cancer
Miami, Florida
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:19+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Inflammatory Breast Cancer, Metastatic Disease, Connective Tissue Disorder, BRCA Mutation, Others
276 Participants Needed
Pembrolizumab for Triple-Negative Breast Cancer
Miami Beach, Florida
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Active Liver Disease, Others
Must Be Taking:Pembrolizumab
1295 Participants Needed
Hormone Therapy with or without Radiation for Breast Cancer
Miami Beach, Florida
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 70
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Mastectomy, Non-breast Malignancies, Others
Must Be Taking:Endocrine Therapy
1670 Participants Needed
T-DM1 + Tucatinib for Breast Cancer
Miami Beach, Florida
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Cancer, Hepatitis B/C, Others
Must Be Taking:Taxane, Trastuzumab
1031 Participants Needed
Tucatinib + T-DM1 for Breast Cancer
Miami, Florida
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.
Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Untreated Brain Lesions, Leptomeningeal Disease, Others
Must Be Taking:T-DM1
466 Participants Needed
Atezolizumab + Standard Therapy for HER2-Positive Breast Cancer
Miami Beach, Florida
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.
\*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Cardiac Disease, Autoimmune Disease, Others
Must Be Taking:Trastuzumab, Pertuzumab, Taxane
190 Participants Needed
Chemotherapy Combinations for Triple-Negative Breast Cancer
Miami Beach, Florida
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Cardiac Disease, Hypertension, Others
Must Not Be Taking:Sex Hormones, Corticosteroids
782 Participants Needed
Izalontamab Brengitecan for Breast Cancer
Miami, Florida
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Severe Autoimmune Disease, Others
Must Not Be Taking:Anti-PD(L)1, Endocrine Therapies
560 Participants Needed
PF-07220060 + Letrozole for Breast Cancer
Miami Beach, Florida
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer:
* HR-positive (breast cancer cells that need estrogen or progesterone to grow)
* HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
* locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
* who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Visceral Crisis, CNS Metastases, Others
Must Be Taking:Letrozole
1020 Participants Needed
This trial tests a new drug combination for advanced breast cancer patients whose cancer has returned or spread. It compares the new drugs to standard chemotherapy to see if they help patients live longer without their cancer getting worse. The new treatment aims to kill cancer cells directly and help the immune system fight the cancer. Lapatinib is a novel drug currently being tested in advanced breast cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infection, Active Hepatitis, HIV, Others
Must Not Be Taking:Corticosteroids, Anticonvulsants, Antivirals, Others
625 Participants Needed
Camizestrant for Early Breast Cancer
Miami Beach, Florida
This trial is testing camizestrant, a drug that blocks estrogen, in patients with ER+/HER2- early breast cancer at medium to high risk of recurrence. The goal is to see if it works better than standard hormone treatments by stopping cancer cells from growing.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Severe Diseases, Others
Must Be Taking:Adjuvant Endocrine Therapy
4300 Participants Needed
Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer
Miami Beach, Florida
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Breast Cancer, BRCA Mutations, Others
Must Not Be Taking:Endocrine Therapy, HER2-directed Agents
1514 Participants Needed
Dato-DXd +/− Durvalumab for Breast Cancer
Miami Beach, Florida
This trial is testing a new treatment for patients with a specific type of breast cancer who still have cancer after surgery and initial treatments. The treatment uses a drug called Dato-DXd, which targets and kills cancer cells, and may also include durvalumab, which helps the immune system fight cancer. The goal is to see if this new treatment works better than current options.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic TNBC, Autoimmune Disorders, Others
Must Not Be Taking:Immunosuppressants, PD-1/PD-L1 Inhibitors
1174 Participants Needed
This trial compares the effectiveness of a combination of two drugs, SG and pembrolizumab, in patients with advanced triple-negative breast cancer. SG targets and kills cancer cells with chemotherapy, while pembrolizumab helps the immune system attack the cancer. Pembrolizumab has been shown to improve survival in various cancers, including triple-negative breast cancer, when used alone or in combination with other treatments.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors
443 Participants Needed
Giredestrant + Everolimus for Advanced or Metastatic Breast Cancer
Miami Beach, Florida
This trial is testing if a combination of giredestrant and everolimus works better than other hormone treatments plus everolimus in patients with advanced breast cancer who have already tried other treatments. The drugs work by blocking estrogen receptors and a growth pathway in cancer cells. Everolimus has been shown to improve outcomes in breast cancer patients when combined with hormonal treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chemotherapy, CNS Metastases, Cardiac Disease, Others
Must Be Taking:LHRH Agonists
320 Participants Needed
Ribociclib vs. Palbociclib for Breast Cancer
Miami, Florida
HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide.
In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chemotherapy For Advanced Cancer, Others
Must Be Taking:Endocrine Therapy
456 Participants Needed
Giredestrant + Hormone Therapy for Early-Stage Breast Cancer
Miami Beach, Florida
This trial is testing giredestrant, a medication given after initial treatment to prevent breast cancer from returning. It focuses on patients with a specific type of early-stage breast cancer that is hormone-driven and at higher risk of recurrence. Giredestrant works by blocking the hormone estrogen from helping cancer cells grow. Giredestrant has shown promise in previous studies.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Breast Cancer, Cardiac Disease, Liver Disease, Others
Must Not Be Taking:CDK4/6 Inhibitors, CYP3A4 Inhibitors
4200 Participants Needed
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiac Dysfunction, Others
Must Be Taking:LHRH Agonists
992 Participants Needed
Why Other Patients Applied
"I've tried chemotherapy and radiation but the cancer recurred. My oncologist suggested that I might want to try a clinical trial given my situation. Just starting to research, hoping to learn more."
FR
Lung Cancer PatientAge: 71
"I've had radiation and as far as I know I’m in remission, but my brother passed away with the same condition. I don’t mind helping research for a cure... my husband passed away with pancreatic cancer. I've had a stepdaughter that passed away with ovarian cancer at 20. I just think it’s time to knock cancer out! I'd really like to help find better treatments by participating in a trial."
EQ
Lung Cancer PatientAge: 70
"My mom has cholangiocarcinoma with bone mts (FGFR2 mutation). She really needs this trial to survive. She’s active and her analysis is ok, but we have very limited other options. Hope to work with a high-quality clinic to prolong her quality and duration of life."
OF
Cholangiocarcinoma PatientAge: 54
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I had two chemotherapy regímens without success, three surgeries during which the tumor could not be resected. These clinical trials are a light of hope for me and my family (I have a five year old child) and I have read about cases of success in other types of cancer with this treatment. I think that I am a perfect candidate for this tríal. Thank you."
UM
Pancreatic Cancer PatientAge: 48
Capivasertib + Paclitaxel for Breast Cancer
Miami, Florida
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Recent Chemotherapy, Cardiac Issues, Diabetes, Others
Must Not Be Taking:AKT Inhibitors, PI3K Inhibitors
923 Participants Needed
Ribociclib + Endocrine Therapy for Breast Cancer
Miami, Florida
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastases, HIV, Hepatitis, Others
Must Be Taking:Endocrine Therapy
5101 Participants Needed
Omitting Radiation Therapy for Breast Cancer
Miami, Florida
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:35+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Prior Chest Radiation, Others
Must Be Taking:Endocrine Therapy
2140 Participants Needed
Chemotherapy + Atezolizumab for Breast Cancer
Miami Beach, Florida
The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.
Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Cardiac Disease, Autoimmune, Others
Must Not Be Taking:Anthracyclines, Taxanes, Immunosuppressants, Others
1550 Participants Needed
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Invasive Malignancy, Autoimmune Disease, Cardiovascular Disease, Others
Must Not Be Taking:Immunosuppressants, Steroids, Live Vaccines, Others
1174 Participants Needed
Pembrolizumab for Triple-Negative Breast Cancer
Miami, Florida
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Autoimmune, Others
Must Not Be Taking:Immunotherapy, Biologic Therapy
1155 Participants Needed
Targeted Therapy for Metastatic Breast Cancer
Miami, Florida
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, HIV, Liver Disease, Others
Must Be Taking:Anti-HER2 Therapy
518 Participants Needed
Weight Loss Intervention for Breast Cancer Recurrence Prevention
Miami Beach, Florida
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 their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Cardiovascular, Psychiatric Disorders, Others
Must Be Taking:Hormonal Therapy
3177 Participants Needed
Palbociclib + Endocrine Therapy for Breast Cancer
Miami, Florida
This trial is testing whether adding the drug palbociclib to standard hormone therapy can improve treatment for patients with a specific type of early breast cancer. The targeted patients have hormone receptor-positive and HER2-negative breast cancer. Palbociclib works by blocking proteins that help cancer cells grow, potentially making the hormone therapy more effective.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage I/IV Cancer, Chronic Liver Disease, Others
Must Be Taking:Adjuvant Hormonal
5796 Participants Needed
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Severe Co-morbidity, Others
Must Be Taking:Chemotherapy, Hormonal Therapy
129 Participants Needed
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