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Effects of MK-3475 on the breast tumor microenvironment in triple negative breast cancer with and without intra-operative RT: a window of opportunity study.

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT02977468

Population:

Adult

Phase:

I

Are you Eligible? (Inclusion Criteria) Participants must be/have: at least 21 years of age on the day of signing informed consent histologically proven invasive breast carcinoma with triple negative receptor status no evidence of metastatic disease no prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry adequate organ function
Locoregional breast cancer recurrence following targeted intraoperative radiotherapy (IORT) for ductal carcinoma in situ (DCIS)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03216421

Population:

Adult

Phase:

II

The purpose of this study is to examine whether targeted Intraoperative Radiotherapy (IORT) is as effective as external beam radiation in treating DCIS and preventing it from returning. In addition, we will evaluate the side effects of IORT (toxicity), imaging changes, cosmetic appearance of the breast and your quality of life. In this study, subjects with DCIS will have IORT during with breast conserving surgery. Follow-up duration is 5 years. Are you Eligible? (Inclusion Criteria) To be eligible for this trial, patients must be: Female 18 years old or older with DCIS suitable for breast...
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...
S1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03598257

Population:

Adult

Phase:

II

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 defined as care most people get for inflammatory breast cancer when they have already received chemotherapy and had surgery to remove the cancer. Are you Eligible? (Inclusion Criteria) To be considered for this trial, subjects must have:...
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...
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...
The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT04457596

Population:

Adult

Phase:

III

This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing cancer from returning? This study is being done to find out if this approach is better or worse than the usual approach for breast cancer. The usual approach is defined as care most people get for breast cancer. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have HER2-positive breast cancer and have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by...

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