Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:June 14, 2016
End Date:July 31, 2020

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A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

The purpose of this study is determine if the triplet combination of ribociclib, everolimus
and exemastane is effective in the treatment of locally advanced/metastatic breast cancer
following treatment with a CDK 4/6 inhibitor

The purpose of the phase I dose escalation part of this study is to estimate the MTD(s)
and/or identify the RP2D of the combination treatment of ribociclib+ everolimus + exemestane
when dosed continuously in adult men and postmenopausal women with HR+ HER2-negative advanced
breast cancer resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.

The purpose of the phase II portion of this trial will be to evaluate the anti-tumor activity
of exemestane, everolimus and ribociclib triplet following progression on a CDK 4/6
inhibitor. This part of the study will be conducted using a Simon's optimal two-stage design.

Inclusion Criteria:

- Adult men and women

- Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone
receptor positive breast cancer by local laboratory and has HER2-negative breast
cancer

- Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence
of measurable disease.

- ECOG Performance Status 0 - 1

- Disease refractory to either, AI, tamoxifen or fulvestrant

- Previously treated on any CDK 4/6 inhibitor.

- Patient has adequate bone marrow and organ function.

Exclusion Criteria:

- Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator's best judgment.

- Patient has received more than one line of chemotherapy for advanced disease.

- Previous treatment with mTOR inhibitors, or exemestane for advanced disease.

- Progressed on more than one CDK 4/6 inhibitor

- Patient with CNS involvement unless they are at least 4 weeks from prior therapy
completion.

- Clinically significant, uncontrolled heart disease and/or recent cardiac events.
We found this trial at
27
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Detroit, Michigan 48202
Principal Investigator: Haythem Ali
Phone: 313-916-1784
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441 North Lakeview Avenue
Anaheim, California 92807
Principal Investigator: Jennifer Carney
Phone: 808-432-8587
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Atlanta, Georgia 30342
Principal Investigator: Amelia Zelnak
Phone: 770-496-9420
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Boston, Massachusetts 02114
Principal Investigator: Aditya Bardia
Phone: 617-643-2208
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Boston, MA
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Chandler, Arizona 85224
Principal Investigator: Mikhail I. Shtivelband
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Davie, Florida 33328
Principal Investigator: Elizabeth Tan-Chiu
Phone: 954-582-1850
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Fayetteville, Arkansas 72703
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Fort Myers, Florida 33916
Principal Investigator: Lowell Hart
Phone: 239-274-9930
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Hershey, Pennsylvania 17033
Principal Investigator: Cristina Truica
Phone: 717-531-8678
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Houston, Texas 77024
Principal Investigator: Julio Peguero
Phone: 713-600-0992
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Houston, Texas 77030
Principal Investigator: Meghan Sri Karuturi
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Kansas City, Missouri 64111
Principal Investigator: Timothy Pluard
Phone: 816-932-1601
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Kansas City, Missouri 64132
Principal Investigator: Stephanie L Graff
Phone: 816-276-4700
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Andrew Brown
Phone: 973-322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Los Angeles, California 90095
Principal Investigator: Sara Alsterlind Hurvitz
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250 25th Avenue North
Nashville, Tennessee 37203
Principal Investigator: Denise A. Yardley
Phone: 615-329-7274
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New Haven, Connecticut 06520
Principal Investigator: Tara Sanft
Phone: 203-737-8309
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Orlando, Florida 32806
Principal Investigator: Rebecca Moroose
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Philadelphia, Pennsylvania 19104
Principal Investigator: Amy Clark
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Redondo Beach, California 90277
Principal Investigator: David Chan
Phone: 310-750-3376
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Saint Louis, Missouri 63110
Principal Investigator: Cynthia X. Ma
Phone: 314-362-7249
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Gail L Wright
Phone: 727-216-1143
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San Francisco, California 94143
Principal Investigator: Hope S Rugo
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Santa Maria, California 93454
Principal Investigator: Robert Dichmann
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-383-3366
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Westwood, Kansas 66205
Principal Investigator: Qamar J Khan
Phone: 913-588-2567
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