Attention Laurel Patients:  Effective, Tues May 28th, the new Laurel office is open. The address is 7140 Contee Road, Suite 3500, Laurel, MD 20707……  Attention  Annapolis Patients: The One Community in Care event will be held on June 8th from 11am-2pm in the Annapolis parking lot.

Trial Protocol ID
USOR 23059_CO44657

Investigator
Carol Tweed, M.D.

A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

Trial Protocol ID
USOR 23189_DB-1303-O-3002_DYNASTY-Breast02

Investigator
Courtney Ackerman, M.D.

A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

Trial Protocol ID
USOR 22326_D8535C00001_CAMBRIA-2

Investigator
Carol Tweed, M.D.

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (D8535C00001)

Trial Protocol ID
USOR 22159_CELC-G-301_VIKTORIA-1

Investigator
Jeanine L Werner, M.D.

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-Of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1)

Trial Protocol ID
USOR 22187_D926XC00001_TROPION

A Phase 3 Open-Label, Randomised Study of Datopotamab Deruxtecan (Dato-Dxd) with or without Durvalumab versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple-Negative Breast Cancer who have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

Trial Protocol ID
USOR 20326_TOL2506A_OVELIA

Investigator
Carol Tweed, M.D.

A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy in Premenopausal Subjects with Hormone-Receptor–Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Trial Protocol ID
USOR 21455_WO43571_heredERA

Investigator
Jeanine L Werner, M.D.

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination with Phesgo versus Phesgo after Induction Therapy with Phesgo+Taxane in Patients with Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

Trial Protocol ID
USOR 21462_GLSI-21-01_FLAMINGO

Investigator
Jeanine L Werner, M.D.

A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Trastuzumab-based Therapy (FLAMINGO-01)

Trial Protocol ID
USOR 22080_D8531C00002_CAMBRIA

Investigator
Carol Tweed, M.D.

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Trial Protocol ID
USOR 17079_Flex Registry

Investigator
Tejaswi R. Sastry, M.D.

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene Expression Profiles: An Adaptable Registry (FLEX Registry)