Georgia's Online Cancer Information Center

Find A Clinical Trial

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Status
Completed
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT01942135
Protocol IDs
A5481023 (primary)
Study Sponsor
Pfizer Inc

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the
primary objective of demonstrating the superiority of palbociclib in combination with
fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2
negative metastatic breast cancer whose disease has progressed after prior endocrine therapy.
The safety between the two treatment arms will also be compared. During study treatment, pre-
and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex®
or generic).

Eligibility

  1. Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
  2. Confirmed diagnosis of HR+/HER2- breast cancer
  3. Any menopausal status
  4. Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
  5. On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
  6. Measurable disease defined by RECIST version 1.1, or bone-only disease
  7. Eastern Cooperative Oncology Group (ECOG) PS 0-1
  8. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
  9. Patient must agree to provide tumor tissue from metastatic tissue at baseline

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.