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A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Not Enrolling

Trial ID:NCT03633331

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Protocol #:18-739

877-DF-TRIAL (877-338-7425)

Condition(s):Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7


Principal Investigator:Freedman, Rachel, A

Site Investigator(s):Block, Caroline,
Briccetti, Frederick,
Constantine, Michael,
Faggen, Meredith, G.

Site Research Nurse(s):Bowers, Jordan,
Campbell, Margaret,
Casella, Allison,
Cronis, Charles, Lewis
Dishman, Rachel, C.
Ficociello, Samantha,
Hixon, Nicole, R.
Jeon, Maryangel,
Loeser, Wendy,
Orechia, Meghan,
Pasquale, Kathryn, Mary
Patel, Nikita,

Trial Description:
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Eligibility Requirements:
- Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
- Measurable disease or non-measurable disease
- Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
- No prior therapy with a CDK inhibitor
- Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration
- No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
- No known interstitial lung disease
- No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years
- No active infection requiring treatment with antibiotics
- Patients must be able to swallow and retain oral medication
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patients must be able to read and comprehend English or Spanish
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count >= 100,000/mm^3 (100 x 10^9/L)
- Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)

Protocol #: 18-739

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