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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.
Protocol: 042406Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Protocol: 042409Principal Investigator:
- Susan Pories
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.
Protocol: 042406Principal Investigator:
- Coral Omene
Applicable Disease Sites: Breast -
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Protocol: 042409Principal Investigator:
- Susan Pories
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 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 -
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, 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 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 -
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, 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 -
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