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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 less than or equal to 25 (OFSET).
Protocol: 042313Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
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 less than or equal to 25 (OFSET).
Protocol: 042313Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer.
Protocol: 042315Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer.
Protocol: 042315Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A First-in-Human Study of Mutant-Selective PI3K Alpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer.
Protocol: 042402Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A First-in-Human Study of Mutant-Selective PI3K Alpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer.
Protocol: 042402Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer.
Protocol: 042403Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer.
Protocol: 042403Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated with Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease.
Protocol: 042404Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated with Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease.
Protocol: 042404Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy.
Protocol: 042405Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy.
Protocol: 042405Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase 3, Randomized, Open-Label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination with Physician's Choice Chemotherapy, for the Treatment of Participants with Metastatic HER2-Positive Breast Cancer.
JZP598-303
Protocol: 042406Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
A Phase 3, Randomized, Open-Label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination with Physician's Choice Chemotherapy, for the Treatment of Participants with Metastatic HER2-Positive Breast Cancer.
JZP598-303
Protocol: 042406Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-Label Phase 3 Study.
Protocol: 042410Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants with HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer.
Protocol: 042412Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast