Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Condition: Estrogen Receptor-positive Breast Cancer; HER2/Neu Negative; Stage IV Breast Cancer AJCC v6 and v7
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole; Fulvestrant; Questionnaire Administration; Quality-of-Life Assessment
Intervention description: Given PO; Given PO; Given IM; Ancillary studies; Ancillary studies
Intervention MeSH terms: Letrozole; Fulvestrant; Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      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 criteria:

        Inclusion Criteria:

          -  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)