Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 70 - Any |
Updated: | 3/7/2019 |
Start Date: | August 15, 2018 |
End Date: | August 2024 |
Contact: | Mina Sedrak, MD, MS |
Email: | msedrak@coh.org |
Phone: | 626-218-4173 |
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
This phase II trial studies the side effects and how well palbociclib and letrozole or
fulvestrant works in treating patients aged 70 years and older with estrogen receptor
positive, HER2 negative breast cancer that has spread to other places in the body.
Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant
may work better in treating patients with breast cancer. The trial will explore factors other
than chronologic age that can affect toxicity rates as identified using a cancer-specific
geriatric assessment.
fulvestrant works in treating patients aged 70 years and older with estrogen receptor
positive, HER2 negative breast cancer that has spread to other places in the body.
Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant
may work better in treating patients with breast cancer. The trial will explore factors other
than chronologic age that can affect toxicity rates as identified using a cancer-specific
geriatric assessment.
PRIMARY OBJECTIVES:
I. To estimate the safety and tolerability (adverse event rate) of the combination of
palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen
receptor-positive, HER2-negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To describe the full toxicity profile including all grade 2 and higher adverse events (per
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression
(neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal
(GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue,
neuropathy, and thromboembolism.
II. To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate
median time to treatment failure, including progression free survival and overall survival.
IV. To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.
V. To explore factors other than chronologic age that can affect toxicity rates as identified
using a cancer-specific geriatric assessment.
VI. To describe the results of the Overall Treatment Utility (OTU). VII. To determine the
degree of agreement between patient-reported adverse events (AEs) using Patient Reported
Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.
VIII. To examine the association between sarcopenia and the development of toxicity and
adverse events.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive
letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1
and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
I. To estimate the safety and tolerability (adverse event rate) of the combination of
palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen
receptor-positive, HER2-negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To describe the full toxicity profile including all grade 2 and higher adverse events (per
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression
(neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal
(GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue,
neuropathy, and thromboembolism.
II. To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate
median time to treatment failure, including progression free survival and overall survival.
IV. To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.
V. To explore factors other than chronologic age that can affect toxicity rates as identified
using a cancer-specific geriatric assessment.
VI. To describe the results of the Overall Treatment Utility (OTU). VII. To determine the
degree of agreement between patient-reported adverse events (AEs) using Patient Reported
Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.
VIII. To examine the association between sarcopenia and the development of toxicity and
adverse events.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive
letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1
and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Inclusion Criteria:
- Documentation of disease: estrogen receptor positive, HER2 negative metastatic breast
cancer; histologic confirmation is required
- Measurable disease or non-measurable disease
- Planning to begin endocrine therapy for metastatic disease; one prior line of
endocrine therapy or chemotherapy for metastatic disease is allowed
- No prior therapy with a CDK inhibitor
- Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE
grade =< 1 (except alopecia) prior to registration
- No untreated brain metastases; patients with treated brain metastases must have
completed treatment with steroids to be eligible
- No second malignancies other than non-melanoma skin cancers or cervical carcinoma in
situ
- No active infection requiring treatment with antibiotics
- Patients must be able to swallow and retain oral medication
- Patients must be able to read and comprehend English or Spanish
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count >= 100,000/mm^3 (100 x 10^9/L)
- Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's
disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=<
5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)
We found this trial at
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775 South Main Street
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
![University of Chicago Comprehensive Cancer Center](/wp-content/uploads/logos/university-of-chicago-comprehensive-cancer-center.png)
Principal Investigator: Olwen M. Hahn
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
![Clackamas Radiation Oncology Center](/wp-content/uploads/logos/clackamas-radiation-oncology-center.jpg)
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
![Mercy Hospital](/wp-content/uploads/logos/mercy-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coos Bay, Oregon 97420
Principal Investigator: Alison K. Conlin
Phone: 541-269-8392
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10 Barnes West Drive
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Principal Investigator: Lindsay L. Peterson
Phone: 800-600-3606
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Danville, Illinois 61832
Principal Investigator: Pratima Chalasani
Phone: 800-446-5532
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
![Geisinger Medical Center](/wp-content/uploads/logos/geisinger-medical-center.jpg)
Principal Investigator: Victor G. Vogel
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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210 West McKinley Avenue
Decatur, Illinois 62526
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
![Decatur Memorial Hospital](/wp-content/uploads/logos/decatur-memorial-hospital.jpg)
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
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Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
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1200 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-6212
![Iowa Methodist Medical Center](/wp-content/uploads/logos/iowa-methodist-medical-center.png)
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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700 E University Ave
Des Moines, Iowa 50316
Des Moines, Iowa 50316
(515) 263-5612
![Iowa Lutheran Hospital](/wp-content/uploads/logos/iowa-lutheran-hospital.png)
Principal Investigator: Robert J. Behrens
Phone: 515-241-8704
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Detroit, Michigan 48236
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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17900 23 Mile Road
East China Township, Michigan 48054
East China Township, Michigan 48054
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Elie G. Dib
Phone: 570-422-1700
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East Syracuse, New York 13057
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
![Fairview Southdale Hospital](/wp-content/uploads/logos/fairview-southdale-hospital.gif)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edmonds, Washington 98026
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Effingham, Illinois 62401
Principal Investigator: Pratima Chalasani
Phone: 800-446-5532
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1202 East Locust Street
Emmett, Idaho 83617
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Ephrata, Pennsylvania 17522
Principal Investigator: Dan Sotirescu
Phone: 717-721-4840
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Ephrata, Pennsylvania 17522
Principal Investigator: Dan Sotirescu
Phone: 773-702-9171
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101 S Major St
Eureka, Illinois 61530
Eureka, Illinois 61530
309-467-2371
![Illinois CancerCare - Eureka](/wp-content/uploads/logos/illinois-cancercare---eureka.jpg)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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1717 13th St
Everett, Washington 98201
Everett, Washington 98201
(425) 297-5500
![Providence Regional Cancer Partnership](/wp-content/uploads/logos/providence-regional-cancer-partnership.png)
Principal Investigator: Alison K. Conlin
Phone: 425-261-3529
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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1720 South University Drive
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
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801 Broadway North
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
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801 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6175
![Sanford Medical Center-Fargo](/wp-content/uploads/logos/sanford-medical-center-fargo.jpg)
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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820 4th St N
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6161
![Sanford Roger Maris Cancer Center](/wp-content/uploads/logos/roger-maris-cancer-center.jpg)
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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165 North University Avenue
Farmington, Utah 84025
Farmington, Utah 84025
Principal Investigator: Elizabeth M. Prystas
Phone: 888-424-2100
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Flint, Michigan 48503
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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302 Kensington Avenue
Flint, Michigan 48503
Flint, Michigan 48503
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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302 Kensington Ave
Flint, Michigan 48503
Flint, Michigan 48503
(810) 762-8490
![Genesys Hurley Cancer Institute](/wp-content/uploads/logos/genesys-hurley-cancer-institute.jpg)
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Fort Dodge, Iowa 50501
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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802 Kenyon Road
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Principal Investigator: Robert J. Behrens
Phone: 515-574-8302
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
![Unity Hospital](/wp-content/uploads/logos/unity-hospital.jpg)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Fruitland, Idaho 83619
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
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