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Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135

CompletedPhase 3

Sponsor: Pfizer

Conditions: Metastatic Breast Cancer

Interventions: Palbociclib, Fulvestrant, Placebo, Fulvestrant

Countries: United States, Australia, Belgium, Canada, Germany, Ireland, Italy, Japan

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
* Confirmed diagnosis of HR+/HER2- breast cancer
* Any menopausal status
* Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
* On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
* Measurable disease defined by RECIST version 1.1, or bone-only disease
* Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
* Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

* Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
* Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
* Major surgery or any anti-cancer therapy within 2 weeks of randomization
* Prior stem cell or bone marrow transplantation
* Use of potent CYP3A4 inhibitors or inducers
Locations (247)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Daphne, Alabama, United States
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Avondale, Arizona, United States
  • Chandler, Arizona, United States
  • Flagstaff, Arizona, United States
  • Gilbert, Arizona, United States
  • Glendale, Arizona, United States
  • Glendale, Arizona, United States
  • Goodyear, Arizona, United States
  • Mesa, Arizona, United States
  • Mesa, Arizona, United States
  • Prescott Valley, Arizona, United States
  • Sedona, Arizona, United States
  • Surprise, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Bakersfield, California, United States
  • Culver City, California, United States
  • Duarte, California, United States
  • Fullerton, California, United States
  • Glendale, California, United States
  • La Jolla, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • + 217 more on CT.gov