Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Metastatic Breast Cancer, Aromatase Inhibitors, Palbociclib, Hormone Receptor Positive Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Metastatic (stage IV) breast cancer or locally advanced breast cancer
- Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive, HER2- negative
- Treatment naïve in metastatic or locally advanced setting and planning to undergo treatment with endocrine therapy (ET) and palbociclib OR receiving first-line ET and palbociclib for metastatic or locally advanced disease.
- Premenopausal women and men must be treated with concurrent luteinizing hormone-releasing hormone (LHRH) agonist as would be standard-of-care.
- Evaluable or measurable disease.
- Tissue from a metastatic site must be available within past 6 months prior to therapy initiation.
- Ability to give voluntary informed consent
Exclusion Criteria:
- Any pregnant or nursing woman
- No history of another primary malignancy within past 5 years. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
Sites / Locations
- Johns Hopkins UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A: Participants with untreated metastatic disease receiving ET and a CDK 4/6
Cohort B: Participants initiating a CDK 4/6 i after progression on ET.
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.