Education and Training
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.
Stanford Investigator(s):
Intervention(s):
- drug: PD-0332991
- drug: Letrozole
- drug: Placebo
- drug: Letrozole
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting