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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 -
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2 - Breast Cancer with an ESR1 Mutation.
Protocol: 042501Principal 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 -
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 -
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2 - Breast Cancer with an ESR1 Mutation.
Protocol: 042501Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
An Open-Label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician's Choice in Hormone Receptor-Positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer.
Protocol: 042503Principal Investigator:
- Deborah L Toppmeyer
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 -
An Open-Label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician's Choice in Hormone Receptor-Positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer.
Protocol: 042503Principal Investigator:
- Deborah L Toppmeyer
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 -
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 -
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 -
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 Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination with Chemotherapy versus Placebo with Chemotherapy in Patients with Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease.
Protocol: 042601Principal 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 -
A Multicenter, Open Label, Phase III Extension Trial to Study the Long-Term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.
Protocol: 051804Principal Investigator:
- Eugenia Girda
Applicable Disease Sites: Any Site