NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

Alliance A171601 - "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."

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Cancer Control Clinical Trial

CANCER TYPE: Breast
RESEARCH BASE: Alliance
NCT NUMBER: NCT03633331
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 10/04/2018 (16:51:51)

BRIEF DESCRIPTION

Stage IV breast ca, ER+, Her2-, 70 or older, Palbociclib + Letrozole or Fulvestrant



NOTES


Protocol treatment is to begin within 14 days of registration.

Treatment Plan    (Supplied drug:  None)

 

Palbociclib 125 mg/day Orally Once daily on Days 1-21 of each 28-day cycle  AND

Letrozole 2.5 mg Orally Once daily on Days 1-28 of each 28 day cycle until disease progression or toxicity

OR

Palbociclib 125 mg/day Orally Once daily on Days 1-21 of each 28-day cycle  AND

Fulvestrant 500 mg IM injection Day 1 and Day 15 of Cycle 1, then Day 1 of every subsequent cycle until disease progression or toxicity

 

Letrozole or Fulvestrant is at physician's discretion.



ELIGIBILITY

  • Documentation of Disease: Estrogen receptor positive, HER2 negative metastatic breast cancer. Histologic confirmation is required.
  • Measurable disease or non-measurable disease (see Section 11.3)
  • Planning to begin endocrine therapy for metastatic disease. One prior line of endocrine therapy or chemotherapy for metastatic disease is allowed.
  • 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) prior to registration
  • No untreated brain metastases. Patients with treated brain metastases must have completed treatment with steroids to be eligible.
  • No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ
  • No active infection requiring treatment with antibiotics.
  • Patients must be able to swallow and retain oral medication.
  • Patient Age: ≥ 70 years
  • Patients must be able to read and comprehend English or Spanish.
  • No Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Chronic concomitant treatment with strong inhibitors or inducers of CYP3A is strongly discouraged on this study. Patients on strong CYP3A inhibitors must discontinue the drug prior to registration on the study.
  • Life expectancy greater than 6 months.
  • Required Initial Laboratory Values:
    • Absolute neutrophil count (ANC) ≥ 1500/mm3 (1.5 x 109/L)
    • Platelet count ≥ 100,000/mm3 (100x 109/L)
    • Creatinine clearance ≥ 30 ml/min
    • Total serum bilirubin ≤ 1.5 ULN (< 3 ULN if Gilbert’s disease)
    • AST and/or 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)





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