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Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Principal Investigator:

Katherine D Crew, MD

Contact Number:

212-342-5162

NCT Number:

NCT03418961

Population:

Adult

Phase:

III

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. Are you Eligible? (Inclusion Criteria) Patients must have metastatic breast cancer. There is no limit for number of doses of HER-2 targeted therapy prior to registration. Patients must be at increased risk for cardiotoxicity. Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration,...
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (CCTG MA.39)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03488693

Population:

Adult

Phase:

III

The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from coming back as good as giving regional radiotherapy. There will be about 2140 people taking part in this study. Are you Eligible? (Inclusion Criteria) To be eligible for this study, subjects must: 1. be ≥ 40 years of age. 2. have been...
A Phase 3 Open-label, Randomised Study of DatopotamabDeruxtecan (Dato-DXd) With or Without Durvalumab VersusInvestigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual InvasiveDisease in the Breast

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05629585

Population:

Adult

Phase:

III

The purpose of this study is to learn more about whether an investigational drug called datopotamab deruxtecan (also called Dato-DXd), either alone or in combination with another investigational drug called durvalumab, will work and be safe for the treatment of Triple Negative Breast Cancer TNBC. The term TNBC refers to the fact that the cancer cells do not have estrogen or progesterone receptors (ER or PR) and also do not make any or much of the protein called HER2 (human epidermal growth factor receptor 2). (The cells test negative on all 3 tests.) TIn this study, we will be comparing the...
Cascade Testing In Racially/Ethnically Diverse Relatives of Patients with Breast or Ovarian Cancer (CASSIE)

Principal Investigator:

Katherine D Crew, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

The study is being done to answer the following question: How can we best help women with family members who have cancer and a genetic mutation in a cancer gene make decisions about undergoing genetic testing? We are doing this study because we want to better understand if our web-based tool, RealRisks, can help women with family members who have a genetic variant make an informed decision about genetic testing. Are you Eligible? (Inclusion Criteria) 18 years or older. - Both men and women of all races and ethnic groups are eligible as probands for this trial. Only female first-degree...
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05705401

Population:

Adult

Phase:

III

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 better or worse than the usual approach for your breast cancer. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast...
A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone To Improve Persistence With Endocrine Therapy In Young Women With Stage I-III Breast Cancer (ASPEN)

Principal Investigator:

Claire Sathe, MD

Contact Number:

212-342-5162

NCT Number:

NCT05568472

Population:

Adult

Phase:

III

This study is being done to answer the following question: Will monitoring side effects in between clinic visits help women keep taking their hormone therapy medicine as prescribed for early-stage breast cancer? This study is being done to find out if this approach is better or worse than the usual approach for helping women take their hormone therapy medicine. The usual approach is the follow-up care most people get after they are diagnosed with breast cancer and start hormone therapy. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older, but not yet menopausal? Have you...
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06016738

Population:

Adult

Phase:

III

The purpose of this study is to learn more about the investigational study drug called OP- 1250 (palazestrant) on participants with ER+, HER2- advanced or metastatic breast cancer. OP-1250 is considered endocrine therapy (treatment that adds, blocks, or removes hormones). Estrogen is a type of hormone naturally produced by the body that helps develop and maintain female sex characteristics and the growth of bones. Estrogen can also cause certain types of breast cancer to multiply, grow, and move to different parts of the body. Estrogen works in the body by binding to proteins called estrogen...
A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25

Principal Investigator:

Natalie Berger, MD

Contact Number:

212-342-5162

NCT Number:

NCT05879926

Population:

Adult

Phase:

III

This study is being done to answer the following question: Will the chance of your breast cancer returning be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian suppression? We are doing this study because we want to find out if this approach is better or worse as the other usual approach for your early-stage breast cancer that is sensitive to hormones, is HER2-negative, and is at higher risk for cancer returning. The usual approach for patients who are not in a study is treatment with surgery, radiation therapy, hormonal therapy, ovarian suppression,...
RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE BREAST CANCER

Principal Investigator:

Melissa Accordino, MD

Contact Number:

212-342-5162

NCT Number:

NCT03723928

Population:

Adult

Phase:

NA

The purpose of this study is to determine if overall survival of patients monitored with serum tumor marker direct disease monitoring (STMDDM) is as good as the overall survival of patients monitored with the usual care. Are you Eligible? (Inclusion Criteria) Do you have hormone positive, HER-2 negative, metastatic breast cancer? Are you 18 years of age or older? Are you willing to be monitored for your disease for the duration of this study?
A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05216432

Population:

Adult

Phase:

I

This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA. “Investigational” means that it is not yet known if this drug helps patients, has not been approved by the Food and Drug Administration (FDA) or any other regulatory agency, and is not available for sale as a marketed product...

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