Capivasertib + Palbociclib + Fulvestrant For Hr+/her2
open to eligible people ages 18-99
A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer .
San Francisco, California
Palbociclib Collaborative Adjuvant Study
Sorry, in progress, not accepting new patients
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer . The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
San Francisco, California
New Approach For Triple Negative Breast Cancer
About 10-15% of breast cancer cases are diagnosed as triple negative breast cancer, which means the cancer cells lack all three receptors that doctors can target with cancer-treating medications. As there are currently no effective targeted therapies, triple negative breast cancers have a poorer prognosis compared to other forms of breast cancer.
Research from Associate Professor Chaffers team revealed that triple negative cancer cells switch their cell state in response to chemotherapy, which not only makes the cancer cells more aggressive, but also allows them to evade treatment.
We found that chemotherapy triggers a cell change in cancer cells that enables them to build a defence against the chemotherapy. This means that a different type of cancer cell emerges after treatment, which has become resistant to the chemotherapy and is a major cause of cancer relapse, Associate Professor Chaffer explains.
We aim to put a stop to this cancer resistance strategy to improve the effectiveness of chemotherapy for triple negative breast tumours.
Dr Beatriz Perez San Juan, the post-doctoral researcher in Associate Professor Chaffers lab who led the preclinical study, discovered that activation of androgen receptors in breast cancer cells triggers the cell state switching. Androgens are commonly thought of as male sex hormones but are also found at lower levels in women.
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A Study Evaluating Safety Pharmacokinetics And Therapeutic Activity Of Ro6874281 As A Single Agent Or In Combination With Trastuzumab Or Cetuximab
Sorry, in progress, not accepting new patients
This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics , pharmacodynamics , and preliminary anti-tumor activity of RO6874281 as a single agent or in combination with trastuzumab or cetuximab .
La Jolla, California and other locations
Ft500 As Monotherapy And In Combination With Immune Checkpoint Inhibitors In Subjects With Advanced Solid Tumors
open to eligible people ages 18 years and up
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.
San Diego, California
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Triptorelin With Either Exemestane Or Tamoxifen In Treating Premenopausal Women With Hormone
Sorry, in progress, not accepting new patients
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
San Francisco, California
Pragmatic Randomized Trial Of Proton Vs Photon Therapy For Patients With Non
open to eligible people ages 21 years and up
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of August, 2022, www.radcomp.org.
San Diego, California
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Sayshas Story: Joining A Trial To Help Others
Joining a clinical trial can benefit you as an individual by giving you access to the newest breast cancer treatments and to the attentive, high quality care that clinical trials can provide.
But it can also be an opportunity to help researchers improve outcomes for other people with breast cancer in the future.
Participation in a clinical trial is altruistic, Dr. Chino said. I cant guarantee that it will provide additional benefit for you it may or it may not. But it definitely benefits the next person sitting in your chair.
The chance to help other Black women undergoing breast cancer treatment in the future is what motivated Saysha Wright to join a clinical trial.
Saysha, a mom of two, was diagnosed with breast cancer in 2019 at the age of 32. When she was about to start chemotherapy, her oncologist at Indiana University Melvin and Bren Simon Cancer Center told her about a new trial that could help address a cancer treatment side effect that disproportionately affects Black women.
Black American women have almost twice the risk as women of other races of developing neuropathy nerve damage that causes pain, numbness, and loss of sensation in the hands and feet as a side effect of taxane chemotherapy treatments. If a woman develops severe neuropathy during chemotherapy treatment, it may cause her doctor to lower the dose of chemotherapy or recommend stopping it completely.
Breast Cancer Clinical Trials
Breast cancer clinical trials offer new ways to treat breast cancer and enhance patient outcomes. As a recognized leader in the development of scientific advances for preventing, diagnosing and treating breast cancer, Moffitt Cancer Center is continually performing groundbreaking research, lead by the Breast Program Research Director Dr. Heather Han, who is also a medical oncologist specializing in breast cancer. Our research initiatives allow us to offer our patients a wide range of treatment options, including a variety of clinical trials.
Call today to schedule an appointment. Call us at or request an appointment online.
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Curious About Clinical Trials
Dr. Kathy Miller has been treating breast cancer patients for more than 20 yearsand shes one of the worlds leading experts on breast cancer clinical trials.
Learn how she advises patients about the risks and benefits of participating in a research study.
There is an incredible excitement, as a researcher, to be the first one to see promising results, and to design a clinical experiment to test them. That part of this job never gets old for me.
Kathy Miller, MD Breast cancer physician-scientist
Combination Trials Point To New Potential Treatment Strategies In Breast Cancer
NEW YORK In studies presented at the European Society for Medical Oncology Congress in Paris this weekend researchers continued to make headway in refining combination therapy strategies for patients with triple-positive breast cancer and metastatic HER2-positive tumors.
In the first of these, Fabrice André, a professor of medical oncology at Gustave Roussy in Villejuif, France, presented final overall survival results from monarcHER, a randomized, open-label, Phase II trial of Eli Lilly’s Verzenio with Genentech’s HER2 targeted drug Herceptin and fulvestrant in hormone receptor-positive, HER2-positive advanced breast cancer.
To date, Verzenio, a CDK4/6 inhibitor, has been approved by the US Food and Drug Administration as a single agent and in combination with endocrine therapy, fulvestrant, and aromatase inhibitors for patients with HR-positive HER2-negative breast cancer. The data in monarcHER provides insight into the activity of the drug in HR-positive HER2-positive disease, also known as triple-positive breast cancer.
In monarcHER, 237 patients with HR-positive, HER2-positive advanced breast cancer were randomized to one of three arms of the trial. In arm A, patients received a three-drug combination consisting of 150 mg oral Verzenio with intravenous Herceptin and fulvestrant. Patients in arm B received Verzenio and Herceptin, and those in arm C received Herceptin plus standard chemotherapy.
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A Phase 1/2 Study Of Cyt
open to eligible people ages 18 years and up
This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.
San Francisco, California and other locations
Testing Whether Treating Breast Cancer Metastases With Surgery Or High
Sorry, currently not accepting new patients, but might later
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 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.
La Jolla, California
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Targeted Therapy Directed By Genetic Testing In Treating Patients With Advanced Refractory Solid Tumors Lymphomas Or Multiple Myeloma
open to eligible people ages 18 years and up
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material of patients’ tumor cells. Patients with genetic abnormalities may benefit more from treatment which targets their tumor’s particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
La Jolla, California and other locations
Seven Things People With Metastatic Breast Cancer Want You To Know About Joining A Clinical Trial
We asked members of the Community at Breastcancer.org who have participated in clinical trials for metastatic breast cancer to share the things they think are most useful to know before you enroll. Here are their insights.
If the trial that you join is a randomized, placebo-controlled trial for metastatic breast cancer, youll be randomly assigned to either a test group receiving an experimental medication or a control group receiving the treatment that is the current standard of care plus a placebo. A placebo is an inactive pill or infusion that looks just like the treatment being studied. Placebos help researchers compare the benefits and side effects of treatment with and without an experimental therapy.
In a double-blinded trial, neither the researchers nor the participants know who is getting the experimental medication and who is getting the standard treatment plus a placebo. Double-blinding helps prevent the researchers and participants from having expectations about what will happen and possibly biasing the results.
Youll always be able to find out before you enroll in a trial if theres a possibility that you could receive a placebo .
For example, when Breastcancer.org Community member Gramen decided to enroll in HER2CLIMB, a randomized, double-blinded clinical trial, she knew from the beginning that she could either wind up receiving Herceptin , Xeloda , and the investigational medication tucatinib or Xeloda, Herceptin, and a placebo.
The first one was in 2004.
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Phases Of Clinical Trials
Clinical trials testing new treatments are divided into different phases. Phases 0 to 2 usually look at whether a drug is safe and any side effects it causes. Phases 3 and 4 aim to test whether a new treatment is better than existing treatments.
Phase 4 trials are carried out after a drug has been licensed. They look at drugs which are already available for doctors to prescribe rather than new drugs that are being developed.
You may be asked to join a phase 0 trial, although most trials involving cancer patients start at phase 1.
Find out more about the different phases of clinical trials on the Cancer Research UK website.
Looking For A Way To Support A Loved One With Cancer
Your contributions make a direct and lasting impact on breast cancer researchand we have the success stories to prove it.
The Komen Tissue Bank
In 2007, breast cancer patient and advocate Connie Rufenbarger and her oncologist, Dr. Anna Maria Storniolo, established the world’s only bank of normal breast tissue, blood, and data to better understand the genetics of breast cancer.Today, the Komen Tissue Bank is still the only known biorepository that collects, stores, and annotates healthy breast tissue taken from volunteer women donors who exhibit no signs of breast cancer. Dr. Storniolos work has been instrumental in numerous groundbreaking advances in cancer treatment. With your participation, researchers around the world can continue their lifesaving work.
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Gene Expression Profiling Analysis Studies
The implementation of high-throughput gene expression profiling analysis through DNA microarrays in the seminal studies conducted by the Stanford group, already 15 years ago, led to the identification of the so-called four intrinsic BC subtypes these subtypes are associated with different prognosis, ranging from favorable to poor clinical outcome, as well as with different therapeutic vulnerabilities, and even different patterns of metastatic dissemination10, namely: i) luminal A BC, showing high levels of HR expression, with low proliferation rates and indolent clinical behavior, coupled with sensitivity to endocrine therapeutic manipulations, 2) luminal B BC, showing also HR-positivity, associated however with higher proliferation rates and more aggressive clinical behavior than their luminal A counterparts, with patients having this BC subtype in need of cytotoxic chemotherapy on top of endocrine therapeutic manipulations16, 3) HER2-like BC, characterized at the molecular level byERBB2 gene amplification, affecting also other genes in the same amplicon, with a respective sensitivity to HER2 blockade therapeutic manipulations17, and lastly iv) basal-like BC, largely showing a triple negative phenotype with lack of expression of ER, progesterone receptor and HER2, resulting in aggressive clinical course and lack of molecularly targeted therapeutic options18.
A Study Of Al101 Monotherapy In Patients With Notch Activated Triple Negative Breast Cancer
Sorry, in progress, not accepting new patients
The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC Notch activation will be determined by a Next Generation Sequencing test.
San Francisco, California and other locations
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S1207 Hormone Therapy With Or Without Everolimus In Treating Patients With Breast Cancer
Sorry, in progress, not accepting new patients
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
San Francisco, California and other locations
A Study Of Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Sorry, not yet accepting patients
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive and human epidermal receptor 2 negative . Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
San Francisco, California and other locations
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Other Phases Of Clinical Trials
Not all clinical trials fall neatly into one category. Some trials may be a combination of 2 categories, such as a phase 1/2 or phase 2/3 trial.
Phase 0 trials
Phase 0 clinical trials are different from other phases of clinical trials because they have no treatment goals and they are not part of the FDA approval process .
Phase 0 trials can give information on whether a drug does what its expected to do . For example, the trial may look at whether the drug can reach the cancer and how cancer cells in people respond to the drug .
Phase 0 trials study a very small dose of a drug in a small number of people and last less than a week . The dose of the drug is so small theres no possible treatment benefit . However, this also means the chance of side effects is low .
Although not common, phase 0 trials can be an important first step in human studies of a new drug treatment.
Leveraging The Power Of Technology To Reach Patients Where They Live
Reachingparticipantsin their communities will increaseclinical trial access. Integrating telemedicine into clinical trials allowsparticipants to talk totrial physicians ortheirhealth care providerswithout theadded time andcostsoftraveling to a clinical trial site.To ease additional burdens of clinical trial participation, investments in telemedicine infrastructurewillenable participantsto sign consent formsonline,receive medicationsin the mailoratlocalhealth care facilities,and undergo monitoringfrom afar. With support from the Cancer Moonshot, NCI is also funding research to enhance the engagement of patients in clinical trials and other research studies through technology and online networks.
A survey conducted at Sidney Kimmel Cancer Center at Thomas Jefferson University revealed that 99% of adult patients with cancer who responded were satisfied with their telemedicine visits, and 87% of them felt telemedicine provided the same care as an in-person visit. In addition to learning from real world experiences, NCI has awarded grants to further study how telemedicine has impacted cancer care during the COVID-19 pandemic.
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