Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:


Stanford Investigator(s):


  • Drug: PD-0332991
  • Drug: Letrozole
  • Drug: Placebo
  • Drug: Letrozole


Phase 3


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting