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

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT01740427

Run by

Pfizer

People needed

666

Starts

2013-02-22

Expected to finish

2023-11-09

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Beverly Hills Cancer Center — Beverly Hills, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Los Angeles Hematology/Oncology Medical Group — Glendale, California, United States
• UCLA Hematology/ Oncology- Irvine — Irvine, California, United States
• UCLA Hematology Oncology- Laguna Hills — Laguna Hills, California, United States
• Los Angeles Hematology/Oncology Medical Group — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Translational Research Management — Los Angeles, California, United States
• Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong — Los Angeles, California, United States
• UCLA West Medical Pharmacy: Drug Management Only — Los Angeles, California, United States
• UCLA West Medical Pharmacy; Drug Management Only — Los Angeles, California, United States
• UCLA West Medical Pharmacy — Los Angeles, California, United States
• Administrative Address: UCLA Hematology/Oncology — Los Angeles, California, United States
• Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D. — Los Angeles, California, United States
• Regulatory Management Only: TRIO-US Central Administration — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• TRIO-US Central Administration: Regulatory Management Only — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• UCLA Hematology Oncology — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UCLA Hematology/ Oncology- Pasadena — Pasadena, California, United States
• Torrance Health Association, DBa Torrance Memorial Physician Network — Redondo Beach, California, United States
• Southern California Permanente Medical Group — San Diego, California, United States
• Southern California Permanente Medical Group — Bellflower, California, United States

Full record on ClinicalTrials.gov

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