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OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-Stage Triple-Negative Breast Cancer.
Protocol: 042304Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE).
Protocol: 042305Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
RADIANT Study: Phase Ib Study of Pre-op Radiation with Abemaciclib and Letrozole in Early Stage Breast Cancer.
Protocol: 042311Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
An Adjuvant Endocrine-Based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer.
Protocol: 042312Principal 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 -
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 -
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 -
An International, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age with Hormone Receptor (HR)-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Who Have Not Received Any Prior Systemic Anticancer Treatment For Advanced/Metastatic Disease.
Protocol: 042411Principal Investigator:
- Mridula A George
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 -
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative
(HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor.
Protocol: 042502Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.
Protocol: 042504Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A PHASE Ib/II MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-4198 ALONE AND IN COMBINATION WITH GIREDESTRANT IN COMPARISON WITH ABEMACICLIB AND GIREDESTRANT IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE PREVIOUSLY PROGRESSED DURING OR AFTER A CDK4/6 INHIBITOR
Protocol: 042505Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer.
Protocol: 042506Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer Using ctDNA and HARPS Biomarker Assay.
Protocol: 042507Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast
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