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Open Clinical Trials

Kevin BikeUCLA offers clinical trials not only in Los Angeles but across the United States. 

Search for an open trial below by entering a diagnosis in the keyword search field (i.e., breast cancer, prostate cancer, acute myeloid leukemia). The keyword search finds exact matches only so avoid abbreviations and try different or fewer search terms for broader results. 

Please note that our clinical trials search tool is intended for use as a guide only. Clinical trials information is updated periodically, so there is the potential that a trial listed as open on this site may not be open any longer. Similarly, there may be trials available in addition to those listed here. We recommend contacting the Clinical Trials hotline at (888) 798-0719 to confirm clinical trial availability and/or to get further information about specific trials. 

Some of the information presented for our clinical trials has been obtained from NCI's PDQ Cancer Clinical Trial Registry.

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
IRB#: 13-000187
Principal Investigator: Richard Finn P: 310-586-2091
Coordinator: Monica Rocha

Lay Title:

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

Description:

This study is for postmenopausal women with advanced hormone receptor positive (erstrogen receptor positive (ER+)) breast cancer that has not been treated in the advanced setting (prior treatment for early breast cancer is allowed). The purpose of this study is to see if there is a benefit from the addition of PD-0332991 (Palbociclib) to letrozole versus a standard treatment for this disease, letrozole alone. Palbociclib (PD-0332991) is an investigational agent, which means it has not been approved by the United States Food and Drug Administration for treatment of any disease condition, except for use in a research setting. Palbociclib (PD-0332991) is designed to block proteins called CDK4 and CDK6. Blocking these proteins may prevent or slow down the growth of cancer cells. Results of a Phase II study have shown a significant improvement in progression-free survival for the combination of PD-0332991 and letrozole versus letrozole alone. The current study is a Phase III study designed to confirm this observation. Eligible subjects who decide to enroll in the study will be randomly assigned to one of two groups. One group will receive letrozole in combination with PD-0332991, while subjects in the other group will receive letrozole with placebo (an inactive substance). Since this is a double blind study, neither the study doctor nor the subject will know who is receiving which treatment.

Eligibility:

This study is for postmenopausal female subjects with hormone receptor positive advanced breast cancer.

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Technical Description:

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.

Technical Eligibility:

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.