Status:
COMPLETED
Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of hydroxychloroquine when given together with palbociclib and letrozole before surgery in treating patients with estrogen receptor positiv...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety of adding hydroxychloroquine (HCQ) to continuous low dose palbociclib and letrozole and to determine the recommended phase II dose (RP2D) for hydroxychl...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Diagnosis of estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Postmenopausal defined by: a. Age \>= 55 years and 1 year or more of amenorrhea b. Age \< 55 years and 1 year or more of amenorrhea with luteinizing hormone (LH) and/or follicle stimulating hormone (FSH) levels in the postmenopausal range c. Age \< 55 with prior hysterectomy but intact ovaries with LH and/or FSH levels in the postmenopausal range d. Chemotherapy or medically induced ovarian suppression with 1 year or more of amenorrhea and with LH and/or FSH levels in the postmenopausal range e. Status after bilateral oophorectomy (\>= 28 days prior to first study treatment)
- Absolute neutrophil count (ANC) \>= 1500 cells/ul
- Platelet count \>= 100,000/ul
- Serum creatinine concentration \< 1.5 x upper limit of normal (ULN)
- Bilirubin level \< 1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x ULN
- Alkaline phosphatase =\< 2.5 ULN
- Metastatic cohorts (Phase I): Diagnosis of stage IV estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by ASCO/CAP criteria
- Metastatic cohorts (Phase I): Must be a candidate for treatment with CDK4/6 inhibitor and hormonal therapy with an aromatase inhibitor as standard of care
- Metastatic cohorts (Phase I): No prior exposure to CDK 4/6 inhibitors
- Neoadjuvant cohorts (Phase II): Diagnosis of stage I-III estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by ASCO/CAP criteria. If stage I, clinical tumor size must be \>= 1.5 cm
- Neoadjuvant cohorts (Phase II): Baseline tumor Ki67 \> 5%
- Neoadjuvant cohorts (Phase II): Surgical candidate and appropriate for pre-operative endocrine therapy
Exclusion
- Prior exposure to CDK 4/6 inhibitor therapy
- History of retinal disease or active visual disturbances (normal baseline study-specified retinal exam required)
- Acute illness, including infections requiring medical therapy, known bleeding diathesis or need for anticoagulation
- Treatment with any of the following medications within 4 weeks before the baseline diagnostic biopsy is taken: a. Oral estrogens, including hormone replacement therapy (but prior depot estrogen use not allowed). b. Investigational agents (or 5 half-lives, whichever is longer)
- Required concomitant use of any drug that is a strong CYP3A inhibitor or inducer
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol
- Life expectancy of less than 6 months
- Pregnancy, lactation or planning to be pregnant.
- Neo-adjuvant cohorts (Phase II): Prior therapy for breast cancer (medical, surgical or radiation therapy)
- Neo-adjuvant cohorts (Phase II): Clinical T4 disease
- Neo-adjuvant cohorts (Phase II): Inoperable or metastatic breast cancer based on standard evaluation
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03774472
Start Date
August 20 2018
End Date
April 17 2024
Last Update
February 17 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030