This study is in progress, not accepting new patients

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

a study on Breast Cancer HER2

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Hope Rugo
Headshot of Hope Rugo
Hope Rugo

Description

Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Official Title

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

Keywords

Breast Neoplasms, breast cancer, postmenopausal women, estrogen-receptor positive, HER2 negative, locoregionally recurrent, metastatic, Palbociclib (PD-0332991), PALOMA-2, Letrozole, Palbociclib, PD-0332991 + Letrozole

Eligibility

You can join if…

Open to females ages 18 years and up

  • Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease.
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
  • Eastern Cooperative Oncology Group [ECOG] 0-2
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

You CAN'T join if...

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.

Locations

  • University of California, San Francisco
    San Francisco California 94115 United States
  • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94158 United States
  • Stanford Women's Cancer Center
    Stanford California 94304-5826 United States

Lead Scientist at UCSF

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01740427
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 666 people participating
Last Updated